Jobs Posted through July 4, 2008
Jobs That Crossed My Desk Through August 30, 2009
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
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THIS LOOKS LIKE A VERY EXCITING AND UNIQUE CAREER OPPORTUNITY. THIS WAS PASSED TO ME BY DAN LANGFORD AT THE ROBERT GORDON UNIVERSITY IN THE UK (SCOTLAND). I'D BE GRATEFUL IF YOU MIGHT BE ABLE TO POST THIS ON YOUR WEEKLY JOB LISTING.
I copy the full job description below. Interested candidates should contact Dan Langford at:
Phone: +44 (0)1224 262 159
Mobile: +44 (0)7717 272 325
Email:d.langford@rgu.ac.uk
LinkedIn:
Chief Executive Officer—this is in the UK
Job Summary:
Needed to lead a spin-out company from a world-class University and to build an exciting, proven innovation in molecular in vitro diagnostics into a successful business.
Job Description:
Working with academic team members, the preferred candidate will lead the ongoing development and implementation of the business strategy and bring to the table negotiation, marketing and sales experience and a track record of building successful teams in a spin-out situation.
Our ideal candidate will be self-starting and entrepreneurial and is expected to make a leading contribution to the business planning process through extensive personal networks. It is envisaged that the individual will contribute significantly to licensing, collaboration and fundraising activities enabling the business to develop to the next level.
The ideal individual would have the following competencies:
• Extensive experience gained in human diagnostics and a knowledge of laboratory automation
• Demonstrated knowledge of contract negotiation early stage intellectual property
• Ability to build and manage a small, focussed team
• A Proven track record of closing licensing and investment deals
• Experience in raising equity funding from venture capital providers and/or business angels
• Relevant network of industry contacts with potential customers and development partners
• Experience of the corporate governance and financial management obligations of managing an SME, ideally as executive director of a company
Key tasks:
• Providing strong leadership and direction for the organization including clinical development, commercialization and all operational areas such as Marketing, IT, HR, Legal, Facilities and Finance
• Working with the project team to develop and implement policies and procedures, achieve short- and long-range goals, strategic objectives and plans of the project and spin-out company
• Leading a cohesive management team and other internal and external collaborative groups
• Represent the company at global events through relevant meetings, delivery of formal presentations and other business development activities
• Analyse and balance commercial, financial and technical factors to make sound business decisions
• Build strong, long term relationships with industry partners to achieve performance goals
Job Level:
Senior Management
Register Now to view the company details and apply on line.
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WD_DARSHANA@
DARSHANA NADKARNI LOOKING FOR CATHETER ENGINNER FOR MILPITAS, CA - (EXCITING TECHNOLOGY, SECURE IP) TO WORK ON DEVELOPING PACEMAKER & NEUROSTIMULATION LEADS.
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USES THE INTERNET TO CONDUCT TRADE SHOWS FOR THE PHARMACEUTICAL AND LIFE SCIENCE INDUSTRIES. BESIDES HAVING VIRTUAL EXHIBITS, WE ALSO HAVE A CLICK-BY-STATE JOB BULLETIN FOR BOTH EMPLOYERS/RECRUITERS AND JOB SEEKERS TO USE. THERE IS ONE NEW INTERESTING POSITION WITH THE NIH:
Clinical Medical Officer – $149,000 per year
Please go to our job bulletin job and click on the state of interest or use our Advanced Search Functions to search for jobs. Please read the job descriptions carefully and follow the descriptions to apply.
We are also launching a new service called ePharmaCards – unique eCards with science and pharma themes. Pls be free to check them out.
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For more information contact Christy Sterbenz, Project Manager with BeakerSource at csterbenz@ or visit me on LinkedIn-
POSITION: SENIOR MARKETING MANAGER
LOCATION: BAY AREA, CA
Position Summary:
Working with the most dynamic and evolving medical device organization in the country, the Senior Marketing Manager will contribute significantly to the commercial strategy and performance at the company.
In this capacity, the Senior Marketing Manager will develop, lead, and implement marketing plans, key marketing programs, and offer direct support in driving adoption of the company’s surgical system into new and pre-existing procedures across the healthcare industry.
Principal Responsibilities:
The Senior Marketing Manager will:
❑ Work directly with the sales organziation to drive forward marketing initiatives within a defined category of therapy.
❑ Establish and develop call points with surgeons and physicians.
❑ Develop and implement clinical education programs and symposia to drive competency and utilization of the system
❑ Develop and implement live surgical broadcasts via the web to educate and promote the system for target General Surgery procedures
❑ Take ownership of therapeutic/vertical markets in marketing communications for the purpose of downstream marketing exposure to surgeons and physicians for the surgical system.
Key Selection Factors:
1. The candidate will have industry experience from the medical device, medical product or medical equipment industry with products specified or marketed directly to physicians.
2. The candidate will have an undergraduate degree in a related course of study. Advanced degrees, including an MBA, a Masters degree in a life science, or medical training are preferred but not mandatory.
3. The candidate will have specific accomplishments in marketing, preferably beyond pure product marketing and extending to management of a category of therapy or having actively owned market development of a product or therapy.
4. The candidate will have experience in ‘downstream’ marketing, preferably in direct interactions with clinical practitioners, end customers and a large, clinically savvy sales force.
We are looking for bright, achievers with demonstrated energy to take ownership of the product and ensure success for themselves as well as the company.
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MicroCube – the medical device incubator where I work is looking for the following people:
1. Mfg. Process Engineer
2. Regulatory specialist
3. Engineering interns (can be fresh graduates)
Please refer to the page on our website for more details. The interns will be hired as a starting step to a potential full time position
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Steve Burke, Sr. Recruiter
Foxhunt Staffing, Inc.
(650) 941-4237
(650) 941-4260 fax
steve@
Job Title: Product Manager – Global Product Innovation
Department: Marketing
Reports to: Product General Manager
SUMMARY
This position has direct ownership for the design and development of key elements of the product portfolio, and leads customer-driven product development efforts in both product and software. Candidate will be responsible for transforming marketing or business requirements into impactful product features and services, and overseeing and managing the development and delivery into the marketplace. In-market feature performance, post-launch improvements, future product enhancements and new product ideation are also areas of focus for this position.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
• Transform marketing requirements into viable and impactful products and/or product features that meet specific customer needs. Work with cross-functional teams on creating detailed product requirements and use cases, as well as user experience requirements to ensure customer needs are met. Understand cost and timing impacts.
• Create (when necessary) and own business requirements documents that outline key product improvements or changes.
• Work closely with cross functional teams within the organization – including R&D, IT, clinical, and manufacturing to drive product requirements through design, development, testing and launch. Validate that the product going to market is meeting the requirements and is expected to achieve the anticipated impact.
• Develop a deep understanding of our customers (Dentists and Orthodontists) through primary and secondary research, market visits and close sales relationships. Incorporate this understanding into product requirements that are consistent with the long term customer experience vision.
• Validate and improve upon product requirements through user experience reviews, user acceptance testing, and pilot management as appropriate. Work closely with cross functional teams and marketing partners on the commercialization of product launches. Work with Professional Education, clinical, legal/regulatory, customer marketing, customer care, and sales teams to deliver best-in-class product improvement launches.
• For assigned products: monitor on-going health, adoption metrics, and feature usage; collect internal and external feedback; investigate, prioritize, and implement improvements and enhancements to maintain and/or increase benefits of product; work with international counterparts to determine international product development / release plans; determine version or product phase-out plans as appropriate.
EDUCATION and/or EXPERIENCE
• BS or BA required, MBA a plus.
• A minimum of 5-7 years working in product development organizations, with demonstrated successful launches.
• Proven track record of setting product development targets and delivering results a must.
• Experience in medical device or dental product development preferred.
• Self-starter, work in a fast pace environment with the ability to manage and deliver multiple projects.
• Excellent communication and organization skills
• Ability to work well in team (marketing and cross-functional) environment
• Strong project management skills
PHYSICAL DEMANDS & WORK ENVIRONMENT
• There are no specific physical demands required for this position.
• The organization is an exciting, medical devices and e-business company with a highly sought after and proprietary product. The atmosphere is casual and the company is extremely employee oriented with stock-purchase & other competitive compensation plans. There are abundant professional growth opportunities for qualified individuals.
WORK SCHEDULE / HOURS
• Regular business hours
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FYI. If interested, contact Robin Kumar
Robin Kumar
(973) 993-9383 Ext.3477
Robin_Kumar@
Subject: Immediate need of Clinical research Associate - B
My name is Robin and I'm a recruiter at Artech.
Artech has an urgent contract for one of our direct clients:
Job Title: Clinical Research Associate- B
Location: Santa Clara, CA 95054
Duration: 6+ months
Order Number # 10530
Job Description:
Minimum 5 years of CRA experience, preferably in Medical device field.
Ensure timely collection of study documents.
Maintain and control all necessary records.
Oversee upto 25 clinical sites, through follow up phase and protocol amendments.
If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (973) 993-9383 Ext.3477, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.
Artech is a global IT Consulting company with over 30 Fortune 500 customers. You may visit our website at to learn more about us
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Ruba Khenaisser
Resumes to rkhenais@.
I have 2-6 month opening for a Project Coordinator with a Biotech company in South San Francisco.
We need someone with strong Document Control experience and preferably experience with Documentum and/or Sharepoint. This person should be highly organized to track project status and performance for an integration project. Candidates with any type of project coordinator experience can be considered, so long as it's within a biotech or medical device field (R&D, IT, Manufacturing, etc.)as long as candidate has strong document control and project tracking experience.
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Nancy J. Symonds
President
NJS Recruiting Services
415-491-1541
njs@
I'm writing to ask for your assistance in our efforts to identify candidates for three Manager positions in the areas of Down Stream Purification, Fermentation, and Filling and Finishing. I have attached the job descriptions for your review. There is flexibility to consider candidates at the Associate Director level.
Our client is a growing specialty biopharmaceutical company dedicated to developing the next generation of innovative products in dermatology and aesthetic medicine. They are located in the San Francisco Bay Area.
The company has developed a platform technology which enables topical, needleless, delivery of botulinum toxin and other macromolecules across skin. Our client is in the process of developing a next generation injectable form of BoNT-A that incorporates key elements from the platform technology. The objective of that program is to improve onset and duration of action while eliminating human or animal components in the formulation
Thank you so much for taking the time to review these job descriptions. If someone you know has the skill sets we are looking for, please have them send a CV to njs@ for consideration. If there are any questions, please don't hesitate to call me. I look forward to hearing from your referrals.
NJS Recruiting Services is an executive search firm specializing exclusively in Biotech and Pharmaceutical searches in various areas of drug development. We have been in business since 1994 and are located in the San Francisco Bay Area of California. We work primarily with companies also in the Bay Area. This enables us to develop closer, professional relationships as we visit with our clients regularly at their location.
Job Description
Job Title: Manufacturing Manager, Filling and Finishing
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Filling and Finishing, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the drug product manufacturing process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Implement and run an aseptic cGMP manufacturing process for production of a lyophilized drug product.
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Aseptic processing experience including vial preparation, filling and capping.
Large-scale lyophilization of drug product vials required.
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
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Job Description
Job Title: Manufacturing Manager, Downstream Purification
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Downstream Purification, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the purification process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Implement and run a cGMP protein purification process for an API.
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Protein purification processes, including chromatographic separation, centrifugation, and filtration.
Experience with AKTA Pilot chromatographic skids.
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
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Job Description
Job Title: Manufacturing Manager, Fermentation
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Fermentation, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the fermentation process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Large-scale bacterial fermentation experience
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
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Interested parties should submit resumes at
E-mail resume: fionna.mabeliso@amo.
Business Excellence Leader (BPI)*
Santa Ana OR Milpitas, CA
This Senior Level Process Improvement Manager Role is responsible for the execution and ongoing management of service and operational excellence initiatives in the Global Customer Service Organization. The role leads strategic, complex process improvement projects in conjunction with division goals and imperatives for increasing revenue, optimizing cycle time, reducing defect rates, and improving customer satisfaction. The role requires well developed leadership and project management capabilities with demonstrated success completing core-business, cross-functional, and cross-cultural projects. The role is accountable for delivering strategic results from the application of Six Sigma methodologies and effective change management.
• Leads strategic, complex process improvement projects across GCS and the division.
• Delivers strategic results in conjunction with divisional goals and imperatives.
• Evaluates business processes and determines initiatives that will yield greater productivity and efficiency to enable growth.
• Acts as a cross-cultural change agent to drive and sustain measurable business process improvements internal and external to GCS.
• Act as a mentor, coach, and technical leader in the implementation of Abbott Business Excellence best practices.
Qualifications
• BS/BA required; advanced degree preferred in a business, science, or engineering discipline.
• 10+ years of experience delivering strategic results from BPI initiatives.
• Current Black-Belt certification; Master Black-Belt certification desired.
• Proven expertise in application of Lean and/or Six Sigma to deliver business process improvements.
Other Essential Skills:
• Ability to negotiate and influence key personnel across multiple business units and geographies.
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Interested parties should submit resume: fionna.mabeliso@amo.
Apply:
Program Engineer III, Biomedical Optics—Milpitas, CA
Our principal aim is to develop advanced, life-improving vision technologies for people of all ages. This current opening is within the laser vision correction R&D group and requires skill in excimer laser development, optical systems design and with attendant instrumentation. You will be developing commercial medical devices in a design control environment through teamwork with software developers as well as with electrical, mechanical, and quality engineers.
Experience with laser-material interaction processes is essential as we develop new and more effective methods to reshape the human cornea. In our fast-paced, high-tech environment, success is based on creative invention skills, thoughtful project planning, hands-on experimentation, and thorough analysis. The successful candidate will be able to work on two parallel projects, in a mix of team environments, and as an individual contributor.
QUALIFICATIONS
- Portfolio of demonstrated creativity in solving complex UV pulse generation, beam shaping, and beam delivery design challenges in biomedical devices, laser lithography, material processing or similar areas.
- Applied expertise with excimer lasers and optical engineering principles.
- Demonstrated proficiency with programming and optical design software (ZEMAX or Oslo, Code 5, etc.)
- Analytical mind, readily applies product development processes for Change Management, VOC, VOB, DOE, Requirements specifications, Design Control, V&V.
- Hands-on system architect who takes broad thinking to detailed implementation.
- Excellent written and oral communication skills.
- Motivated to shine as part of a development and cross-functional team.
- Driven to lead in a fast-moving high-tech industry.
KEY DUTIES AND RESPONSIBILITIES: % OF TIME OR IMPORTANCE
1. Applying analytical thinking, experimentation, and computer modeling skills to expand AMO’s knowledge of laser/tissue interaction mechanisms to develop methods that reshape the human cornea more effectively and predictably 35
2. Design, specify and validate laser beam generation, beam shaping and beam delivery subsystems for medical UV excimer lasers that optimize performance, reliability and cost-of-goods 35
3. Perform error budget analysis for the LVC process chain as design input into performance improvement projects (treatment alignment, workflow) 20
4. Generate intellectual property and review current patent publications on laser based ophthalmic procedures 10
EDUCATION and/or EXPERIENCE
- Requires a minimum of Master’s Degree and 8+ years of relevant experience. Advanced degree preferred.
- 4+ years demonstrated optical or opto-mechanical design experience.
- Experience with UV lasers & optics required.
- Demonstrated experience with the product development lifecycle.
- Superior written and spoken communication skills plus a track record of cross-functional teamwork.
Abbott is an Equal Opportunity Employer and maintains an Affirmative Action Plan
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John Pandes
Senior Staffing Consultant
Gilead Sciences, Inc.
O: (650) 522-5599
Email: John.Pandes@
Senior Medical Writing Specialist
Foster City, CA or Durham, NC
This role can be located in either Durham , NC or Foster City, CA. (Telecommuting is not an option ~ sorry.)
Specific Responsibilities and Skills for Position:
Experience writing CTD submission summaries and overviews, briefing documents, development plans, as well as CSRs and IBs. Knowledge of antiviral and/or cardiovascular TAs a plus.
Essential Duties and Job Functions:
Prepares a wide range of regulatory documents, including clinical study reports, Investigator Brochures and Annual Updates, as well as more complex CTD summaries and regulatory responses, in-line with regulatory requirements and Gilead internal document standards. Contributes to other non-regulatory medical writing activities as required. Participates in submission teams providing advice/guidance for optimal presentation of data for achievement of document objectives. Leads document timeline/resource planning within the submission team. Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines. Medical writing activities are performed independently with little direction from Associate Director / Director level. Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions. Leads/contributes to development work in relation to document standards, continuing MS template development and other aspects of document management. Provides submission team contact point regarding requirements for regulatory documents. Participates in both group and moderately complex Company-wide process improvement and development initiatives.
Knowledge, Experience, and Skills:
Specific pharmaceutical: Typically requires a BA degree and minimum 10 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, which includes 5 years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions. General scientific: Typically requires a BA degree and minimum 10 years of relevant experience or a MS degree and minimum of 8 years of relevant experience or a PhD, MD or DVM degree and minimum 4 years of relevant experience. Demonstrated success in the preparation of regulatory documents particularly at the individual study report level. Highly developed and proven medical writing skills. Excellent verbal communication skills. Knowledgeable of regulatory document requirements/guidelines. Understands moderately complex document management, authoring and publishing tools and their applicability for workflow efficiency. Well-developed computer skills including proficiency in Word, Powerpoint and Excel. Use of project management tools and graphics packages also desirable.
If you are interested in being considered for these positions or if you know someone who is qualified, please contact me. I'd appreciate any referrals.
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Interested candidates please send resume to:
Vince Graziano
Scientific Medical Writer
Northern NJ Industry: Major Pharmaceutical Company
Salary: $75-$105K
Description:
The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Qualifications:
Requirements: Bachelor's degree or equivalent, with at least six years experience in scientific discipline and a minimum of four years in Medical Writing. Master's degree, PhD, or equivalent with a minimum of two years previous industry experience. Demonstrated working knowledge of scientific principles. Excellent written and oral communication skills in English. Familiarity with all phases of medical research and ability to learn new medical concepts quickly. Familiarity with statistics and experimental design. Ability to summarize complex data and identify relationships.
Must have Clinical Study Reports and Regulatory submissions experience.
contractrecruiter@
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Medical Writer, Medical Communications (Multiple Positions)
San Francisco Bay Area
Anyone interested or if you know anyone looking, please contact me via
email at shannonp@.
Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
(518) 843-4611 ext. 252
shannonp@
sheilagreco. com
Celebrating 20 Years of Excellence
Medical Communications Agency:
Medical Director- must have PhD, PharmD, or Md degree and medical communications agency experience
Sr. Account Manager
Account Manager
Speakers Bureau Manager
_____________________________________________________________________________
Pharma Advertising Agency:
Account Supervisor or Group Account Supervisor
************************************************************************************************* Contact Suzanne George, Sr. Partner
MRI Weston if you meet the reqs.
Suzanne George, Sr. Partner
MRI Weston
Management Recruiters of Weston
Visit our website:
Linkedin:
2645 Executive Park Drive
Weston, FL 33331
954-385-3122
Our client, an established California based Global Medical Device company,
advantageously located in the East Bay Area between San Francisco and San
Jose is seeking the following positions:
Six Sigma Black Belt: Principal Engineer
Principal Engineer will be responsible for the Six-sigma process & design
expertise for mechanical team, with focus on product, process, and test
methods for class III medical devices with technical responsibility for
interpreting, organizing, executing, and coordinating assignments.
Conceiving and assigning plans, conducting research in problem areas of
various scope and complexity that require unconventional or novel
approaches, and require sophisticated research techniques Responsibilities
include:
* Serving as the global technical expert in the application of advanced
theories, concepts, principles, and processes for an assigned area of
responsibility (i.e., subject matter, function, type of facility, or
equipment, or product)
* Keeping current of new methods and developments affecting his/her area,
team or product, recommending changes or new programs
* Evaluating project teams progress and results, recommending changes to
achieve overall objectives. Technically supervise other engineers or
technicians on particular projects, which may or may not be related to
current assigned projects
* Responsible for product design characterization to ensure successful
Design Verification and Validation and developing and validating in-vitro
test methods and for performing design reviews and re-validation assessments
to ensure the safe and environmentally sound start-up of new processes
* Responsible for the purchase or design of equipment that meets health,
safety and environmental standards set by the company
Requirements:
* Education & Experience: BS degree with 14+ years of related
engineering experience; MS with 12+ years of related engineering experience;
Ph.D. with 9+ years of related engineering experience
* Must be a "solid engineer" with a mastery of theoretical and
practical fundamentals and experimental engineering techniques with a
required background in prototypes and design control
* Six Sigma Design or Process Excellence Black Belt certification is
required (Will NOT accept green belt) PE License is a PLUS
* Requires proven ability in Statistical analysis
* 4+ years experience in the medical device industry including
required experience with in vitro product testing
* Other PLUSES: Design valuation experience, vascular access and
Materials Background
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Principal Engineer: Balloon Design
Principal Engineer in Balloon Design will work on complex problems where
analysis of situations or data requires an in-depth evaluation of various
factors. Determines direction and adequacy of designs and test results and
recommends changes. Conceiving and assigning plans, conducting research in
problem areas of various scope and complexity that require unconventional or
novel approaches, and require sophisticated research techniques
Responsibilities include:
* Responsible for extrusion and balloon design in alignment with product
CTQs; Understanding of the relationship between inputs and balloon design
output is essential for success of this position and serve as subject matter
expert on balloon material
* Interactions with environmental and processing conditions
* Strong understanding of IP landscape in order to identify potential
design solutions as well as support Legal department
* Process and / or Design Excellence approach to design,
characterization, and implementation; Develop and implement detailed plans
and systematic processes to proactively manage and address internal and
external product needs; DOE and statistical analysis of data with
responsibility of report writing
* Take-charge, hands-on approach to proactively manage extensive number
of competing design requirements and communicate limitations to the team
* With Sr. Mgmt support, drive accountability and ownership of critical
project milestones
* Coordinate activities with R&D Design Control Systems team and various
Quality teams
* Supports regulatory filings and internal/external audits as needed
Requirements:
* Education & Experience: BS degree with 14+ years of related engineering
experience; MS with 12+ years of related engineering experience; Ph.D. with
9+ years of related engineering experience
* MUST have polymer materials design experience and possess a mastery of
theoretical and practical fundamentals and experimental engineering
techniques
* Experience as team lead is a requirement, not necessarily management of
people but technical lead.
* 4+ years experience in the medical device industry including required
experience with in vitro product testing
* PE License, Six Sigma Design, Black or Green Belt certification a PLUS
* Other PLUSES: Intellectual property experience, Stent
design/development and Design Control
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Principal Engineer: Catheter Design
Principal Engineer in Catheter Design will work on complex problems where
analysis of situations or data requires an in-depth evaluation of various
factors. Determines direction and adequacy of designs and test results and
recommends changes. Conceiving and assigning plans, conducting research in
problem areas of various scope and complexity that require unconventional or
novel approaches, and require sophisticated research techniques
Responsibilities include:
* Serving as the global technical expert in the application of advanced
theories, concepts, principles, and processes for an assigned area of
responsibility (i.e., subject matter, function, type of facility, or
equipment, or product)
* Keeping current of new methods and developments affecting his/her area,
team or product, recommending changes or new programs
* Evaluating project teams progress and results, recommending changes to
achieve overall objectives. Technically supervise other engineers or
technicians on particular projects, which may or may not be related to
current assigned projects
* Responsible for product design characterization to ensure successful
Design Verification and Validation and developing and validating in-vitro
test methods and for performing design reviews and re-validation assessments
to ensure the safe and environmentally sound start-up of new processes
* Responsible for the purchase or design of equipment that meets health,
safety and environmental standards set by the company
Requirements:
* Education & Experience: BS degree with 14+ years of related engineering
experience; MS with 12+ years of related engineering experience; Ph.D. with
9+ years of related engineering experience
* Must have Catheter Design, IV product development and VOC experience
and possess a mastery of theoretical and practical fundamentals and
experimental engineering techniques
* Experience as team lead is a requirement, not necessarily management of
people but technical lead.
* 4+ years experience in the medical device industry including required
experience with in vitro product testing
* PE License, Six Sigma Design, Black or Green Belt certification a PLUS
* Other PLUSES: Intellectual property experience, Stent
design/development and Design Control
NOTE: RELOCATION ASSISTANCE IS AVAILABLE FOR ALL THREEPROSITIONS.
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Jobs That Crossed My Desk Through August 23, 2009
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Please send resume to Darshana Nadkarni at wd_darshana@.
There is an immediate job opening for a Catheter Engineer. Requirements include Bachelors in Engineering plus minimum 5 years experience working in teams developing catheter systems, from conception through production with minimal supervision. Ideal candidate will have demonstrated ability to contribute in all phases of new catheter product development including ideation, concept development, detailed engineering, and design for manufacturing. This is an exciting opportunity in early stage company with promising technology, solid funding, and secure IP. Responsibilities include, ability to work with other members of the product development team to conceive, develop, prototype, test and debug novel catheter systems in accordance with established policies, goals, and objectives.
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For those interested in medical devices, check out Acclarant; it is doing lots of hiring:
California Openings
Cost Accountant
Customer Service Manager
Director, Marketing
Director, Quality Assurance
IT Specialist
Marketing Product Manager
Principal Process & Product Development Engineer
Receptionist / Administrative Assistant - We have two part-time positions available
Regulatory Project Manager
Senior Document Control Specialist
Senior Machinist
Senior Manufacturing Engineer
Senior Marketing Manager
Senior Process & Product Development Engineer
Senior R&D Engineer
Senior R&D Engineer
Senior R&D Technician
Senior Sales Operations Analyst
Quality Engineer Consultant
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Janet Jarboe
Jarboe and Associates
JanetJarboe@
(OFFICE) 970-686-5899
(MOBILE) 970-689-2962SERVING PROFESSIONALS SINCE 1997
For twelve years Jarboe and Associates has specialized in placements for small, mid-size, large and pre-IPO companies.
Our staff identifies opportunities and candidates in Pharmaceutical Technologies, Pharmaceutics and Drug Delivery, Analysis and Pharmaceutical Quality, Regulatory Science, PPDM, Process Analytical Technology, Drug Design and Discovery, Clinical Sciences and Writing.
Our goal is to effectively communicate and conduct efficient and confidential searches.
Position Descriptions are attached below.
Jarboe and Associates runs a very confidential business and we look forward to your feedback and being of assistance to you, your company or colleagues.
Analyst/Sr. Analyst, Process Development - California
This position will be responsible for performing and designing protein analyses in support of the monoclonal antibody development projects at company. Essential functions include, but are not limited to the following:
• Perform analytical testing of intermediates and final products following SOPs.
• Perform a wide range tests such as: HPLC, SDS Page, ELISA, pH, appearance, UV, IEF, A280, etc.
• Maintain detailed records of assay performance; analyze and interpret test results.
• Recognize results that deviate from established standards, and recommend appropriate actions. Perform testing necessary to investigate out-of-specification test results.
• Recommend revisions to procedures to improve efficiency and ensure compliance with regulatory requirements and internal procedures.
• Establish SOPs for new assays, materials, products and equipment.
• Effectively and efficiently train other analysts in the performance of complex test methods.
• Comply with good housekeeping and company safety practices.
Position Requirements:
•Position requires science degree in Biochemistry or related discipline with 3-5 years experience in the Biotechnology industry.
•Candidates should possess strong protein analytical skills, expensive hands-on experience with HPLC and ELISA, SDS Page is required, and proficiency with CE and MS is desired.
•Should have knowledge of GMP, FDA, and USP regulations and a basic understanding of statistics.
•Strong organizational, communication and interpersonal skills required, with an ability to flexibly work in a fast-paced multi-tasking environment.
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Director/Senior Director, Molecular Discovery - California
• The successful candidate will support Executive Vice President and Head of R&D in the management of all aspects of molecular biology related to target discovery and validation and development of novel cancer therapeutic monoclonal antibodies (MAbs), including gene discovery and analysis, molecular profiling, bioinformatics and modeling systems, antibody engineering, gene expression modulation, target and antibody product-related expression systems, gene characterization of unique cancer cell populations, and other molecular applications to support pr-clinical and clinical activities.
• The candidate will also participate in activities related to molecular characterization of biomarkers associated with company’s MAb products. Responsibilities include the identification and implementation of novel technologies for facilitation of such activities.
• The candidate will supervise groups with relevant activities and will work closely with other Research and Development Directors and their teams in a cross-functional environment to advance research and pre-clinical programs.
• The candidate will work closely with teams to facilitate collaborations related to research and pre-clinical activities.
Position Requirements
X Advanced degree (Ph.D., or equivalent) with at least 10 years experience in an industry setting, molecular biology, molecular genomics, bioinformatics and related areas. with demonstrated track record of
X Proven record in design and implementation of activities related to gene discovery and characterization, gene profiling, bioinformatics,
X Demonstrated record in driving scientific and technical innovations, as evidenced by first or senior authored publications in top-tiered journals
X Demonstrated successful program leadership and multi-project coordination
X At least 5 years of management experience of multiple groups
X Proven track record in leading programs to achieve goals and timelines
X Ability to perform successfully in a cross-functional team environment
X Excellent written and verbal communication skills
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Target Discovery – California
We are seeking a highly motivated scientist with strong background in molecular biology or related field with microarray chip, bioinformatics and cancer biology experience in a biopharmaceutical organization. The position involves target discovery and biomarker identification for therapeutic antibody development, including experimental design, data mining, target review, expression profile validation and target candidate selection. The successful candidate is expected to work creatively, independently and collaboratively in a dynamic team environment.
Responsibilities include microarray chip experimental design, specimen processing, data mining, gene characterization at the genomic level, and expression profiling by qPCR. The position requires application of various molecular biology techniques, cell signaling, protein biochemistry and data analysis skills to design, execute and interpret experiments. In addition, the candidate will be involved in interfacing with scientists within cancer research and antibody development areas, writing reports and timely communicating results to other members of multidisciplinary teams.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
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Associate Scientist/Scientist, Tissue Analysis Group - California
The successful candidate will employ immunohistochemical and microscopy techniques to screen and identify novel antibodies for use in immunohistochemistry, determine target antigen expression in both animal and human tissues, perform tissue cross-reactivity studies and analyze the biomarker expression and pathology of tissues received from in vivo antibody efficacy studies.
The incumbent will be required to independently design and conduct experiments including interpretation of results, analysis of data and preparation and presentation of reports.
As an Associate Scientist/Scientist there is significant opportunity for scientific collaboration and leadership. The individual will participate in project teams to provide presentation and interpretation of immunohistochemical results as well as becoming a prospective project leader in the validation of a therapeutic antibody target. The ability to work as part of a multi-disciplinary team to design, implement and execute experiments is vital.
Position Requirements:
o A PhD in Cancer Biology, Pathology or a related field
o Proven record of research capabilities, as evidenced by publications and/or patents
o Skilled in microscopy and sample interpretation
o Experienced in digital image acquisition and image analysis
o Proficient in performing immunohistochemistry on paraffin and frozen tissue sections
o Experienced in fixation, processing and embedding of tissues as well as frozen and paraffin embedded section preparation
o Self-motivated and demonstrable leadership capability
o Excellent organizational skills to balance work load between several projects in a fast paced environment in order to accomplish assigned objectives
o Strong interpersonal and communication skills and the ability to work in a team environment
• Knowledge and experience in biopharmaceutics, toxicology, toxicokinetics, ADME and pharmacokinetics with therapeutic antibodies and antibody drug conjugates
• Knowledge of FDA regulations pertaining to non-clinical and clinical drug development.
• Well developed oral and written communication
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Director, Regulatory Affairs – California – reports to Vice President Operations
Responsible for development and execution of global regulatory strategies and regulatory agency interactions. Regulatory role spans pre-IND and early clinical development of antibody products for proprietary cancer targets in multiple solid tumors. Position is a key member of product development team and interfaces regularly with research, manufacturing, quality and clinical organizations within company global operations. Position is “hands-on” and also includes coordinating the preparation and submission of all regulatory documents and reports to FDA and equivalent international organizations.
Requirements:
-Bachelor’s degree in life sciences, Chemistry, Biology preferred. Advanced degree is a plus.
-8-10 years previous biotechnology and/or pharmaceutical drug development experience.
-Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.
-Recognized as an expert in regulatory strategy and submissions.
-A minimum of 5 years regulatory affairs experience preferably involving direct contact with the FDA; full knowledge of FDA & ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
-Proven record of successful IND/NDA submission and negotiations with the FDA. Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
-Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members. Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
-Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence and direct staff and colleagues and groups within company global organization. Highest integrity with respect to professional standards and maintenance of proprietary, confidential information.
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Associate Director/Director, Toxicology Lead– reports to Vice President, Development – California
Directs and manages company’s toxicology programs for therapeutic MAbs. Prepares non-clinical development plans including necessary studies and their timing. Designs and reviews preparation of protocols for non-clinical toxicology/toxicokinetic studies. Performs site visits and makes site selection decisions. Serves as Toxicologist on Program Development Teams. Reviews, provides comments and approves study reports for toxicology and toxicokinetic non-clinical studies. Prepares and reviews non-clinical toxicology sections in documents (IND, IDB, BD, NDA) and responses to regulatory agencies.
Position Requirements • Ph.D in toxicology, biochemistry, pharmacology, pharmacokinetics or related sciences; minimum of 10 years of pharmaceutical industry, including 7 years in toxicology and management experience
• Comprehensive knowledge of drug development (non-clinical and clinical)
• Experience with non-clinical CROs
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Formulation Development Scientist
The successful candidate will play a key role in developing and implementing formulations for the development products of company’s anti-cancer monoclonal antibody. The scientist will interact with the functional groups in the Development, QA/QC, and CMC teams to define and oversee strategy for formulation development. Essential responsibilities include but are not limited to:
• Lead the design and execution of experimental programs to develop phase I and II clinical formulations
• Supervise pre-formulation activities, such as (pH-dependent) solubility, stability, and excipient compatibility testing of new products
• Develop formulations of adequate stability for research, pharmacology, toxicology and early clinical studies
• Characterize prototype formulations and support development of corresponding analytical methods
• Develop and scale-up of formulation processes using DOE.
• Maintain a current awareness of formulation and delivery technologies.
• Maintain a current awareness of and enforce applicable government regulatory, safety, occupational health, and environmental requirements.
• Work closely with other Research and Development teams, actively supporting testing of new drug formulations at various stages of development, meeting project timelines and goals
• Contribute to CMC sections for regulatory filings.
Position Requirements: • Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Experience in the pharmaceutical industry is preferred in formulation development or related biochemistry related areas of development (e.g. purification, stability, analytical).
• Experience working with monoclonal antibodies and exposure to early phase formulation development activities
• Experience with IV formulations as well as formulation development for poorly soluble compounds would be desirable.
• Proven experience managing the scale-up and manufacturing of parenteral dosage forms
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
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Purification Development Scientist
The successful candidate will play a key role in developing, characterizing, validating, and implementing monoclonal antibody purification processes from laboratory to pilot scale. The scientist will apply engineering and biological expertise to collaboratively develop and optimize purification processes suitable for cGMP manufacturing, and will interact with the teams within Process Development as well as collaborate with members from Manufacturing, Quality Control, Quality Assurance, and the Biotechnology Labs of company in Japan. The scientist will also be responsible for new technology development and process optimization as it benefits company current and future purification platforms. Essential responsibilities include but are not limited to:
• Design, develop, and implement recombinant protein purification and recovery processes from laboratory to pilot scale using mammalian cells
• Serve as a technical expert in protein purification within the organization and provide support to the equipment and documentation requirements of GMP manufacturing suites and development laboratory
• Work with Manufacturing and assist for technology transfer to cGMP manufacturing, provide technical support/ and support troubleshooting of existing processes.
• Work both independently and in collaboration with the Purification Process Development team and ensure that corporate objectives are met.
• Write and review documentation to support regulatory filings
• Generate, analyze, and report results of experiments and present at meetings within company.
Position Requirements • Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Knowledge of the design, optimization and scale-up of purification processes is a necessity. Direct experience with purification process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred.
• Hands-on experience with protein purification unit operations such as centrifugation, clarification, precipitation, chromatography and ultrafiltration.
• Knowledge of protein biochemistry and competence in routine protein analytical characterization tools such as HPLC, electrophoresis, and spectrophotometry is also required.
• Process validation and cGMP experience is desirable.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
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Project Manager - Southeast
-experience in mergers and acquisition.
-MUST be fluent in Japanese.
-5-7 years experience
-MBA preferred, but not required.
-Project Management experience required
Manager Medical Publications
Responsible for the development of scientifically and medically accurate publications for company’s marketed products. Interacts with other functions; Regulatory, Medical, DDPM, Legal, Marketing and other departments. Serves as primary liaison with internal and external opinion leaders, investigators, authors, and affiliates on publication activities related to the therapeutic area. The goal is to ensure the appropriate integrated communication of scientific communications, a process of quality, speed, and consistency to provide maximum effect of critical scientific information.
• Develop integrated publication strategies detailing the appropriate scientific communication for marketed products within the therapeutic area
• Coordinate the publication plans to identify potential for collaboration and resource sharing; impact messaging across compounds; and to maximize data effect at selected venues for therapeutic area
• Analyze published data and determine strategies to enhance literature base on company products
• Interact directly with Clinical, Statistics, Regulatory Affairs, Marketing, and Medical to understand communication objectives for the therapeutic area and develop appropriate scientific communications
• Review current educational message platform, plan and processes; identify areas for improvement to increase quality, process and cost efficiency; facilitate actions for improvement
• Shared responsibility to define and maintain database “best practices”
• Review manuscripts, abstracts, and poster content as appropriate
• Attend review meetings conferences, symposia and other meetings as necessary or as assigned and act as liaison between Strategic Publications and external content contributors
• Manage Strategic Publications budget for therapeutic area
• Determine need for, timing of, and content of publication advisory boards
• Manage publications vendor
• Maintain current knowledge on publishing industry standards and best practices and apply them to business
Position Requirements: Health Care Professional preferred, with at least 3-5 years in clinical practice, and/or 3-5 years of pharmaceutical industry experience required.
• 3-5 years of publications and editing experience
• Significant project management experience
• Effectively work with and lead cross functional teams
• Excellent written and oral communication skills
• Working knowledge of pharmaceutical clinical development and product life-cycle management
• Significant experience and knowledge of clinical trial reports, data presentation, and interpretation.
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Associate Director, Clinical Data Management - Colorado
Requirements:
• BA/BS with 10 years data management experience in a biotechnology/pharmaceutical setting or MS/MA with 5 years data management experience
• 5 years experience managing a staff of 5+ employees
• Experience with clinical data management, clinical study database design and implementation, and generation of clinical study reports
• Experience with electronic data capture system (EDC); experience with Medidata RAVE and ARISg desirable
• Knowledge of commercial coding tools and clinical databases and programming, and experience utilizing them to code medical terms and medications
• Works effectively as a member of multiple teams and has the ability to lead these teams
• Strong interpersonal and communication skills, both oral and written
• Strong knowledge of the clinical drug development process
• Familiarity with regulatory submissions
Summary:
Reporting to the VP Biostatistics and Data Management, this position is responsible for directing and supervising all activities associated with the data management department, processes through clinical trials, and overall quality and integrity of the clinical data. This position will manage a group of six Clinical Data professionals.
Responsibilities:
• Leads and directs the Clinical Data Management department, sets the tone of the department through example, and coordinates activities of the department in order to meet project deliverables
• Keeps abreast of industry trends to efficiently capture data from clinical trials using electronic data capture systems (EDC), clean the data, and lock databases in a timely manner
• Writes and updates Standard Operating Procedures (SOPs) and Work Instructions (WIs), as needed
• Provides data management input for all clinical trial synopses and protocols prior to the design and implementation of EDC databases
• Ensures electronic case report forms (eCRFs), eCRF completion instructions, and data validation specifications are completed prior to implementation of EDC databases
• Executes study-specific procedures compliant with regulatory and internal requirements and supervises and mentors others to do so
• Represents Clinical Data Management in project team meetings
• Supports the generation of clinical study reports
• Oversees the supervision of CRO data management activities, which includes evaluating and selecting CRO vendors and working with project leaders and clinical team members
• Assumes responsibility of special projects, programs and studies as needed
• Works with other departments within Clinical Development to optimize study conduct by facilitating communication, defining roles, building efficiencies and mentoring direct reports to do so
Management:
• Supervises, mentors, and trains Clinical Data Management team members
• Sets the tone of the department through example
• Coordinates activities of the department in order to meet project deliverables and timelines
• Identifies and reports study conduct trends to the head of Biostatistics and Data Management
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Clinical Manager - title to be determined - also requires GLP QA experience – New Jersey
description available soon, please let me know if interested
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Manager / Associate Director of Analytical Development – NJ – established outsourcing model transitioning to full pharma
Main Duties & Responsibilities:
-Identify, select, and manage CROs providing analytical chemistry services.
-Lead the development of analytical procedures in support of pharmaceutical drug substance and product development projects.
-Responsible for process improvement activities.
-Able to zero in and identify areas of opportunity for improvement of analytical methods.
-Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMPs, company's SOPs and protocols.
-Ensure that all laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of -Specification (OOS), Changes or Deviations in Data, are conducted promptly and thoroughly
-Convey results of analytical studies and participate in project discussions within development teams.
-Keep up to date with technical advances in analytical and pharmaceutical sciences.
-Stay abreast of current trends in regulatory requirements in the field of CMC.
-Responsible for preparation and/or review of the analytical chemistry portion of the CMC section of a drug product submission.
-Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products
-Review and approve all analytical method development protocols and reports.
-Review and approve all release and stability specifications.
-Manage the activities of one chemist in to ensure that studies are completed in accordance with project timelines and expectations.
Requirements:
-Ph.D., M.Sc. or B.S. in a science related to Pharmaceutical Analysis
-Ph.D. with 6 years or M.Sc. with 10 years or B.S. with 12-15 years of pharmaceutical analytical development experience in the pharmaceutical industry
-Good understanding of analytical method validation requirements of pharmaceutical industry
-Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization
-Candidates must have a good theoretical knowledge of chromatographic sciences and spectroscopic technologies e.g. UV, IR, MS, NMR, XRD
-Very positive interests in keeping up to date with new technologies and developments in analytical sciences
-Good understanding of cGMP, ICH and FDA requirements
-Comfortable working in a “virtual” environment
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Building world class Clinical Pharmacology group for stable, successful, large company.
Seeking candidates for positions to be filled in 2010.
1) Clinical Pharmacology seeking candidates with Pop PK experience. (3 positions)
2) Experimental Medicine seeking candidates, M.D. and/or PhD, can consider those with all academia experience/ industry experience welcome (3 positions)
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Research Leader, Toxicologist- New Jersey established outsourcing model transitioning to full pharma
Description:
Research Leader for toxicology section responsible for all aspects of toxicology from early discovery through clinical development support.
The successful candidate should have strong interest and experience in toxicological sciences to undertake and lead the discovery and regulatory toxicology studies. The toxicologist participates fully on Project teams and subteams, and has frequent interorganizational and outside collaborative contacts.
Regulatory work includes the planning, conduct, reporting and review of toxicology studies, including peer-reviews.
Additional responsibilities include:
Review study protocols and make recommendations regarding the design of the non-clinical toxicology and anatomic pathology portions of toxicology studies.
Conduct gross examinations of animal tissues from toxicology and investigative studies and interpret and explore the significance of results.
Qualification:
PhD and/or DVM in Toxicology with DABT
Over 10 years experience in toxicology pharmaceutical development
Knowledge and experience in FDA regulations pertaining to non-clinical and clinical drug development
Strong scientific background and the ability to critically assess scientific toxicology data
Extensive experience in animal necropsy Experience in pathological evaluation would be a plus
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Research Leader, Veterinary Pathologist – New Jersey –established outsourcing model transitioning to full pharma
Research Leader for pathology section and is responsible for all aspects of pathology from early discovery support through clinical development.
The successful candidate will have the opportunity to evaluate and interpret outcomes from both discovery and regulatory toxicology studies. The pathologists participate fully on Project teams and subteams, and have frequent interorganizational and outside collaborative contacts.
Regulatory work includes the planning, conduct, reporting and review of toxicology studies, including peer-reviews.
Additional responsibilities include:
-Support drug discovery and development by providing pathology support in the design and conduct of toxicology experiments which focus on characterizing the safety of novel therapeutic targets and discovering and developing new chemical entities intended to modulate those targets. ---Review study protocols and make recommendations regarding the design of the clinical pathology and anatomic pathology portions of toxicology studies.
-Conduct gross and microscopic examinations of animal tissues from toxicology and investigative studies and interpret and explore the significance
of results of clinical pathology, organ weight, necropsy, and histopathology data.
-Create or contribute to pathology reports that accurately and completely reflect the data collected and the significance of the data to drug registration and human safety.
-Provide investigative pathology leadership for drug discovery teams.
Qualification: This position requires a DVM preferably with PhD in Pathology or a related field and Board-certified/eligible by the American College of Veterinary Pathologists. Familiarity with Good Laboratory Practice (GLP) guidelines and 3-5 years experience working in pharmaceutical industry. Proven ability to communicate clearly and effectively and to foster productive dialog on complex topics is required as well as the ability to contribute effectively to sound decision making in a manner that is timely and consensus based. The ability to introduce new ideas, practices and technologies
to effectively enhance the drug development process is expected.
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Numerous positions for Medical Doctors with Industry experience (Illinois & California) including those listed below
-Medical Director to Executive Director/VP –GERD
-Medical Affairs Director, Latin America
-Medical Director, Medical Science - Oncology
-Senior Medical Director, Medical Science – CNS
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Sr. Manager/Assistant Director, CMC – Illinois
Responsible for planning and/or coordination of CMC and related activities for multiple projects with minimal guidance from departmental senior management (Senior Director or Vice President). Leads or coordinates the conduct and timely completion of CMC tasks for assigned projects, including internal input regarding internal project strategy and strategic plans with development collaboration partners. Leads or coordinates the identification, selection, and supervision of contract organizations including contract formulation, manufacturing and/or analytical method development labs as for both drug substances and drug products. Prepares budgets and other strategic forecasts for assigned projects.
1. Plans and/or coordinates execution of the drug substance and drug product development activities between PTM (Pharmaceutical Technology Management) and external development or contract organizations for assigned projects, with minimal guidance from supervision, to assure timely development, registration and commercialization of investigational drug products.
2. Represents PTM on global and local project teams to input on CMC scientific strategy and tactics. This includes strategic and tactical leadership of project teams which involve external development collaboration partners.
3. From a technical and business standpoint, leads or coordinates the identification, evaluation and selection of appropriate organizations for development and commercial manufacturing activities. Coordinates these activities with those of other departments (QA, Legal, Supply Chain, Procurement) as needed to assure that selection and implementation is efficient and effective. Provides substantial input and leadership, as needed, regarding the preparation and negotiation of development and supply agreements.
4. Leads or makes substantial scientific contributions to strategic CMC project teams for assigned projects. Identifies technical or resource issues, and takes independent remedial action if needed to prevent delays in timelines. Works with management to negotiate appropriate project deliverables with project teams, and interacts with other project team members to resolve questions or issues as required assuring that project deliverables are on time.
Position Requirements: • A M.S. or Ph.D. in Pharmacy, Pharmaceutics, life sciences or Chemistry plus 3-5 years of experience in the pharmaceutical development of investigational drug candidates is required. A B.S. in Pharmacy or Chemistry with additional relevant experience (5-10 years) can be considered. Title and grade will be based degree and experience as well as the degree of fitness to the Essential Job Responsibilities
• Experience with multiple aspects of the process development, analytical characterization, process scale-up and/or regulatory registration of biotechnology drug substances proteins or peptides) is required.
• A thorough knowledge of current pharmaceutical and related industry and processes and practices, and the ability to leverage this knowledge to optimize group and departmental processes is essential.
• Experience in the management of contract research organizations or collaboration partners is preferred.
• Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external organizations.
• The ability to manage multiple projects and to work well within a team environment are also essential.
• An working understanding of GMP requirements and FDA/ICH guidance is required, as well as facility with commonly available computer tools for project management and data evaluation.
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Manager, Clinical Pharmacology
Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to LWT and GWT for multiple drug development programs with minimal management supervision. Responsible for clinical PK/PD study design, protocol preparation, implementation, data analysis
and study report preparation. Responsible for managing the activities of personnel associated with conduct of Clinical PK/PD studies and assurance
of compliance with SOPs, and FDA and ICH regulations. Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs.
PK/PD Expertise. Provides PK/PD input to the strategic development plans for multiple drug development programs with minimal supervision from department management.
2. Planning/Protocols. Designs and prepares protocols for clinical PK/PD studies with minimal direction.
3. Site Selection. Provides input in making site selection decisions; assesses overall site quality on an ongoing basis; helps resolve site problems; supports CRAs and Sr. CRAs on site-related issues.
4. Planning/Budget. Evaluates clinical study resources and proposes changes as necessary. Prepares CRO and site budget proposals. Monitors expenditures and payments.
5. Data Analysis. Performs clinical PK and PD data analysis using a variety of software programs and using external resources as necessary.
6. Project Management. Manages projects to ensure completion to meet established objectives in accordance with SOPs and FDA/ICH requirements. Coordinates internal resources (e.g., drug supply, data management, biostatistics); forecasts and manages drug and drug supply needs for development programs. Provides interim reports to Biopharmaceutical Sciences management and project teams regarding subject enrollment and overall study conduct.
7. Study Reports. Prepares and reviews study reports for completed PK and PD studies. Prepares and reviews PK and PD components of study reports for completed Phase II/III studies.
8. Regulatory Documents. Prepares the PK/PD components of Briefing Documents, INDs and NDAs with minimal supervision from department management.
9. Presentations/Publications. Participates in project reviews and presents study status and results to
APUS management. Attends professional meeting and presents study results as appropriate. Publishes study results as appropriate.
10. SOPs and Regulations. Understands APUS SOPs, regulations/guidelines governing drug development (FDA, ICH, cGCP) and ensures that they are followed.
11. Training. Participates in on-going training and in the training of Sr. CRAs, CRAs and Clinical Research Specialists.
12. Other. Duties as assigned by supervisor.
Position Requirements: PhD, Pharm.D, MS, BS in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Five years of Phase I clinical trial experience or equivalent. Knowledge of Clinical Research Organization industry for clinical trials. Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans. Proven project and time management skills
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Pharmacokineticist, Clinical Pharmacology
Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) information needed to make a sophisticated design of clinical pharmacology studies based on advanced PK/PD modeling & simulation including population pharmacokinetic approaches (Pop PK) to project teams for multiple drug development programs from a variety of therapeutic areas. Assist in preparation of the Clinical Pharmacology development plan. Support clinical study managers across projects. Responsible for the preparation of PK analysis plan, data analysis and preparation of PK/PD components of study reports. Assist in preparation of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies. Responsible for assurance of compliance with SOPs, and FDA and ICH guidelines and regulations.
PK/PD Expertise. Provides PK/PD and Pop PK input to the strategic development plans for multiple drug development programs in a variety of therapeutic areas. Recognized as an expert in PK/PD and Pop PK both inside and outside the company.
2. Organization. Anticipates and plans for human resources needs; organizes staff, sets goals, timelines and priorities to meet program objectives and establishes appropriate course of action for assigned programs. Provides direction, leadership and learning opportunities to enhance the development of subordinates, if any.
3. Planning. Develops and takes the initiative in preparing the Clinical Pharmacology development plan from PK/PD point of view, including necessary studies and their timing, for integration into the Global Drug Development plan. Interacts and collaborates closely with Clinical Pharmacology of API and for the integration of development strategies
4. PK analysis plan. Designs and prepares analysis plan for clinical PK/PD studies. Designs and prepares population PK/PD component of Phase II/III studies as needed.
5. Site Evaluation. Provides input in making a decision about external resource selection; assesses overall site quality on an ongoing basis; helps resolve site problems; supports Clinical Study Manager on site-related issues.
6. Data Analysis. Performs clinical PK/PD data analysis using a variety of software programs, i.e. WinNonlin, NONMEM and SAS and using external resources as necessary.
7. Program Management. Manage and coordinates internal and external resources (e.g., PK/PD analysis, biostatistics) to provide timely response needed for development programs in accordance with APUS SOPs and FDA/ICH requirements. Provides interim reports to Biopharmaceutical Sciences management and project teams.
8. Study Reports. Prepares and reviews PK/PD components of study reports for completed PK and PD studies and Phase II/III studies.
9. Regulatory Agency Interaction. Support the preparation of the PK/PD components of Briefing Documents, INDs and NDAs with minimal supervision from department management. Represents Clinical Pharmacology in meetings with FDA and other agencies as needed.
10. Presentations/Publications. Participates in project reviews and presents study status and results to management. Attends professional meetings and presents study results as appropriate. Publishes study results as appropriate.
11. SOPs and Regulations. Understands APUS SOPs, regulations/guidelines governing drug development (FDA, ICH, cGCP) and ensures that they are followed.
12. Training. Participates in on-going training and assists in the training of less experienced department members.
13. Other. Duties as assigned by supervisor.
Position Requirements: PhD or Pharm.D in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis, i.e. biostatistics, pharmacometrics. Seven years of Research Data Science or Clinical pharmacology experience or equivalent. Knowledge of global drug development process and ability to design and implement PK/PD and/or Pop PK assessments within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies.
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Lee Gellins
Executive Recruiter
FPC of Hilton Head
843 842-7221 x15
Lee@
MANUFACTURING ENGINEERING MANAGER—Litlle North of LA
Job Summary: Develops and manages engineering resources and efforts for new production programs for company and subsidiaries from the development and prototype stages through to final production stage. Provides technical supports to current production programs. This includes Planning/Business Award, Design, Prototype, Validation, Production Launch and Continuous Improvement.
Supervises: Engineering Teams, Tooling, and Maintenance
Job Duties and Responsibilities: Manage the direct responsibility for all engineering efforts for the personnel who report to the position. Direct responsibility for all Program Management activity and process improvement. Systems implementation, skill enhancement and standardization of policies and practices across the engineering group. Continuous management oversight on products in the development stage. Support design of new products and makes revisions as necessary. Communicates both internally and externally to ensure that projects are running per specifications in terms of cost, quality, and timeliness. Maintain close customer contact to resolve any production problems. Interfaces strongly with manufacturing to support existing product lines. Support the efforts to generates product quotations develop test methods and procedures as needed. Visits customers and vendors as required. Performs necessary functions to adhere to ISO13485, MDD, and FDA standards.
Qualifications: BS in Mechanical Engineering is required with added disciplines in business management a plus. Three to five years experience in managing engineering resources with systems design required. Working knowledge of silicon injection molding and extrusion processes preferred. Previous experience in product design, program management and launching products successfully. Computer literate with knowledge of spreadsheet and word processing packages, and Microsoft Project desirable.
This person should have experience training/mentoring engineers in high production medical device companies.
_________________________________________________________________________________________________
Project Manager-
THE PROJECT MANAGER REPORTS DIRECTLY TO THE ENGINEERING MANAGER. THE INCUMBENT IS AN INDIVIDUAL CONTRIBUTOR, BUT WITH THE RESPONSIBILITY AND AUTHORITY TO LEAD MULTIPLE CROSS-FUNCTIONAL TEAMS. THIS POSITION IS RESPONSIBLE FOR MANAGING NEW PROTOTYPE DEVELOPMENT PROJECTS, AND ALSO NEW PRODUCTION LAUNCHES USING ESTABLISHED ADVANCED PRODUCT QUALITY PLANNING (APQP) PROJECT MANAGEMENT PRACTICES, WITH THE GOAL OF FLAWLESS LAUNCH OF NEW PRODUCTS TO PRODUCTION. PROJECT LEADERSHIP IS PROVIDED FOR ALL PRODUCT LINES MANUFACTURED AT THIS LOCATION OF COMPANY AND ITS SUBSIDIARIES. IN ADDITION, THIS POSITION IS ALSO RESPONSIBLE TO LEAD NEW PRODUCT COST-ESTIMATING AND TEAM FEASIBILITY REVIEWS FOR ACTIVITIES IN SUPPORT OF QUOTING NEW BUSINESS OPPORTUNITIES.
Job Responsibilities
• Provides leadership to manage multiple new prototype development projects, and also new production launches using established project management practices.
• Leads cross-functional teams of resources, drawing from other functional areas, to ensure on-time delivery and a flawless launch to production utilizing best-practices.
• Provides leadership to comply with, and maintains documentation in accordance with Quality System Requirements (QSR), FDA cGMP, internal procedures, customer requirements and notified body requirements.
• Measures, reports, and continuously improves performance metrics (KPIs) of the product development and launch process.
• Assists in development of design standards, cost standards and pricing standards to expedite and provide input for continuous improvement of the quote process.
• Develops accurate and timely manufacturing costs in response to customer or internal inquiries; create new work center costs as needed for cost calculations.
• Reviews, recommends, and directs the “make or buy” decision process.
• Maintains adherence to Company policies, safety/ergonomic standards and good housekeeping practices.
Required Qualifications
• BACHELOR’S DEGREE IN A RELATED TECHNICAL FIELD SUCH AS MECHANICAL ENGINEERING, CHEMISTRY OR PLASTICS ENGINEERING.
• Demonstrated experience providing leadership, managing multiple projects of medium complexity. Proficient in MS Project.
• 5 years minimum of related experience in the medical device industry.
• Working knowledge of ISO-13485 and FDA cGMP regulations.
• Strong business and economic acumen
• Proficiency in basic computer skills (Word, Excel, PowerPoint, etc.) Working knowledge of ERP/MRP software.
• Working knowledge of engineering terminology, extrusion and injection molding processes, tooling and validation protocols.
• Working knowledge of work centers, cost structure, and basic industrial engineering practices.
• Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers.
Preferred Qualifications
• Degree in biomedical or biomechanical engineering is preferred.
• Business degree or progress toward a business degree.
• PMP Certification in Project Management
• APICS certification
• Experience using QAD MFG/Pro ERP software
• Prior experience in a product cost-estimating role
• Lean Systems or Six-Sigma Green Belt Certification is a plus
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Please contact Cheryl Heinla at Cheryl.Heinla@ if interested.
I'm looking for a QA Associate I to work in support of biopharma
manufacturing/warehouse. Someone with a little experience in GMP, raw
materials, label & packaging inspection. Do you know any one on the
junior side from your past work experience who might be interested in
contract in the East Bay?
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Jobs That Crossed My Desk Through August 13, 2009
Thanks for your time.
Sincerely,
Nancy Cody
Wirth & Associates
wirth@wirth-
We are searching for a project management type candidate with experience in mergers/acquisition work.
Pharma experience is not required but, preferred.
The applicant MUST be fluent in Japanese.
5-7 years experience, MBA preferred, but not required. Project Management experience is a definite must.
Compensation up to 110K, Bonus, Stock with a Great Company in Florida.
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Below is a short list of our Hot Jobs, if you have any referrals please contact our office.
GENERAL MANAGER - 34-P-06309
Must have extensive recent experience in aseptic products manufacturing.
$220K+, plus 20% bonus and stock optns.
The General Manager/Senior Plant Director (GM) is responsible for managing all business activities, directing site senior management and developing strategic business initiatives at the site. The GM represents the company on legal/statutory issues with government bodies such as State Department of Health, United States Food and Drug Agency, and Chamber of Commerce officials. The GM interfaces with other pharmaceutical companies, patient groups, scientific organizations, main customers, suppliers, health authorities and key opinion leaders. The GM is responsible for compliance with US/Local employment laws.
_____________________________________________________________________
Technical Supervisor in Quality Assurance, supporting manufacturing Ops. (we'll have more information soon)
Florida
__________________________________________________________________________
Director, Development Quality - 011-06229-TW
$130K 20% bonus, Relo
SUPERVISES: Development Quality Engineers and staff
This position is responsible for the overall maintenance and coordination of quality strategies and quality systems programs, activities and issues for Product Development Process (PDP) for software, reagents and instruments. Processes, controls and oversight consistent with an IVD regulated company will be identified and implemented.
____________________________________________________________________________
Sr./Director, Regulatory - 02-06229-TW
$150K. 20% bonus, Relo
Supervises: Director of Regulatory Affairs, Manager Regulatory Compliance
This position is responsible for the overall development, implementation and coordination of regulatory strategies and activities, with a focus on understanding and influencing legislative/regulatory policy issues and assessing the effectiveness of the Quality System.
Ten to fifteen years of progressively responsible regulatory/quality management experience in the medical device industry. Proven experience negotiating with regulatory agencies, including experience with filing of 510ks, PMAs and IDEs. International regulatory experience valuable. Must have working knowledge of medical device development process and European, US and international regulations, laws and standards covering in vitro medical devices.
___________________________________________________________________________
VP Quality Assurance - 099-07209-Tcjw
Salary: $200-240,000 + Bonus + Stock Options
Global leader in Class III medical devices is seeking a qualified individual to head up all aspects of Quality Assurance for a major division. This person will oversee a very large and diverse staff to include oversite of supplier quality, design quality (design assurance, risk assessment), FDA interface, documentation, plant audits, product transfers, validation, etc.
______________________________________________________________________________
QEs for a client in NC. Classical QE background in pharma. $75K
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E-mail: rcoelyn@
Phone: 817-424-3652
web:
Our Firm is currently working on several executive search projects for lifescience industry clients. We would value your help in identifying some exceptional candidates for two very special clients in particular.
The first client is an emerging medical device company formed to develop enabling and proprietary cardiovascular medical devices. The Company has designed a product that is an embolic protection device which will lower the stroke rate for patients during cardiovascular procedures. The device will be deployed prior to the index procedure utilizing commonly known percutaneous cardiovascular techniques and will be removed after the index procedure. This clever device provides an elegant solution to the problem of cerebral protection during cardiac or aortic procedures and may well become the standard of care in preventing strokes which are presently considered as unavoidable and acceptable risks of these procedures.
The Company has assembled a prestigious scientific advisory board to provide clinical guidance. This board is made up of thought leaders in cardiology, interventional radiology and cardiovascular surgery worldwide.
Senior Director, Regulatory Affairs
The Senior Director, Regulatory Affairs reporting to the Executive Chairman of the Board is a key position. The successful candidate will have a demonstrated track record of success in obtaining regulatory approvals for complex, cutting-edge technology-based Class II and Class III medical device products in the United States, the European Union ("EU"), and Japan.
In order to be considered candidates must be:
• A highly intelligent, seasoned individual with a solid track record, ten (10) to fifteen (15) years in duration, of demonstrated accomplishment in dealing with the FDA (and ideally, international governing bodies) in obtaining regulatory approvals for IDE's, 510(k)'s and PMA's for sophisticated, Class II and Class III medical device products in the cardiology sector. He/she should feel as comfortable with the FDA and senior executives as he/she does in the laboratory and plant. Experience with the FDA Panel process is highly desirable.
• He/she must be intimately familiar with the FDA's CDRH and their current, and especially their emerging practices, policies and procedures.
• A track record of working effectively with physician customers (interventional cardiologists), and of managing customer relations successfully.
The Company is currently very well financed.
Given the uniqueness of the position, the successful candidate can reside anywhere in the US without the need for relocation. That said, he/she must demonstrate the ability to work effectively with a great deal of autonomy.
The second client produces cutting-edge healthcare safety products, including prefilled syringes and sharps safety devices, for the medical device and pharmaceutical industries. Experience in an automated, high-volume, medical device manufacturing environment is required.
______________________________________________________________________
Vice President/Executive Director -- Project Controls Engineering
This person will direct and coordinate project controls services (scheduling, resource planning, and cost analysis) for product development and engineering capital projects, utilizing widely diversified knowledge of project controls activities, and drawing upon extensive experience and exposure to various projects.
This individual will be a key member of the manufacturing operations team and he/she will be located at the Company's primary manufacturing facility which is in Western Pennsylvania.
_____________________________________________________________________
Vice President/Executive Director -- Supply Chain Management
This person will provide leadership and management for all supply chain processes including, but not limited to, selection and qualification of suppliers, negotiation of contracts, sales and operations planning, material forecasting, inventory management and optimization, purchasing, logistics, and warehousing for the healthcare pharmaceutical and medical device industries.
This individual will be a key member of the manufacturing operations team and he/she will be located at the Company's primary manufacturing facility which is in Western Pennsylvania.
We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals.
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Andrew Youngelson
Key Recruit Inc.
You should upload your resume in word doc format at and send me a copy as a Word document. Include a cover letter explaining why you would be a good fit for this position using the keywords in the job requirements as a guide. Letter should include how your work in the past is relative to client needs in the present.
Vice President of Research # 1683- Georgia
|Date Posted: |7/29/2009 |
|Job Id: |1683 |
|Company: |We are a biotech company whose original focus was on chemokine-mediated immune cell migration. Initially structured around |
| |technology licensed from others, we have grown beyond this license to develop an exclusive discovery platform. We currently |
| |own all of our intellectual property and have more than 40 chemical and biological agents that can stimulate cell-type |
| |specific chemotaxis in our portfolio. |
| |-3 Executives , 5 employees-They staff our protein chemistry and screening efforts. Now that we have small molecule leads we |
| |need to establish a drug development team. We expect the new hire to work with SAB to conceptualize work needed to get one |
| |or more leads to IND. One of primary tasks will be to build out the development team. |
| |-Equity Negotiable based on the candidate. |
| |-Company incorporated in 2004. |
| |-As of today we have 18 months of cash. |
| |-Have raised $12 million to date largely from hedge funds that participate in private deals. |
|Location: |Georgia |
| | |
|Reports To: |CEO |
| | |
|Salary: |Compensatory with Exp. Plus Equity. |
| | |
|Education: |PhD or MD or internationally recognized equivalent. |
| | |
|Requirements: |Strong background in Immunology or Cell Biology. 10-15 years of research experience within the pharmaceutical and biotech |
| |industry. Management experience required. Must have had leadership roles that have been involved in preclinical and IND work. |
| |Immunologist would be most useful but willing to look at others. Experience with repurposed molecules, inflammation and |
| |combination products useful. Must be able to build a team. |
| | |
|Duties: |This position is responsible for the overall leadership and strategy and development of compounds in a therapeutic area and |
| |acts as the development and scientific expert to internal and external audiences. Design and execution of in vivo inflammation|
| |studies. Development and implementation of pre-IND program. Management of research associates. Works closely and communicates |
| |frequently with Senior Management, Consultants and Scientific Advisors. |
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uses the internet to conduct trade shows for the pharmaceutical and life science industries. Besides having virtual exhibits, we also have a click-by-state Job Bulletin for both employers/recruiters and job seekers to use. There are a couple of new interesting positions:
Sales Account Management – Pharma Software (San Francisco)
Medical Director / Medical Writer (Philadelphia, PA)
Please go to our job bulletin job and click on the state of interest or use our Advanced Search Functions to search for jobs. Please read the job descriptions carefully and follow the descriptions to apply.
We continue to receive many requests from employers and recruiters to search our resume database. We encourage job seekers to post their resumes on our website to make themselves visible to our inquiring employers. We wish you the best of luck!
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Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
Tel: (650) 825-2932
Fax: (650) 825-2992
Email: rkhenais@
View my LinkedIn Profile
I don’t typically work on these types of positions but they come up from time to time so I thought I’d let you know so you can pass to your network. It’s a contract position. They are interested in candidates with any type of Healthcare, Biotech, or Medical Device background though Behavioral Health is the top priority.
Product Manager with healthcare company in San Francisco:
Activities include coordinating the delivery of multiple projects, developing cost benefit analyses for the program, communicating to an executive committee, creating and reporting program status utilizing a dashboard, allocating resources across the multiple projects, defining project governance policies and managing the financial concerns of the program. Must be able to utilize and effectively communicate technical components of an initiative to applicable parties. Must have experience working with product deliverables and working with marketing.
Ideal candidate will have a product management background in the Behavioral Health field.
The preferred location of the candidate is in San Francisco, CA but position could also office from Golden Valley, MN.
Anyone interested can send their resume to me at rkhenais@ and I will follow up accordingly.
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lists jobs for several pharma companies with positions across many functions.
Life Technologies is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Read more...
View Open Positions at Life Technologies
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Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
Tel: (650) 825-2932
Fax: (650) 825-2992
Email: rkhenais@I thought I'd check in and provide an update on what's going on with opportunities through our SF/Peninsula office especially as we have received an influx of positions over the past few months and also, this week! (Hopefully this is a sign the times are changing!):
-Supplier Quality Engineer (5 openings)
-Sr. Process Development Technician
-In-Coming Quality Inspector
These are all contract opportunities in the Peninsula Area. Anyone qualified and interested in exploring these opportunities is encouraged to send a resume to rkhenais@. With the new SQE openings, I obviously have my work cut out for me so any help with high-quality referrals is greatly appreciated! It's good karma :-)
Also, I am holding a networking event for medical device industry professionals on August 20th. The only requirement to join the group is that you have medical device industry experience or education that is catered towards the medical device industry. Please contact me with your resume or summary of your medical device background for further details at rkhenais@
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Jobs That Crossed My Desk Through August 9, 2009
Joy@
407-898-4440 x 104
Interviews will be next week for an immediate hire.
Product Development Engineer - Orthopedic (Senior Role) San Francisco Bay Area
The Product Development Engineer for this hyper-growth implant company will play a significant role in new product development, “next generation” planning and development and work closely with surgeons and marketing group to analyze, define, and meet customer needs. Using your prior product development and technical background in Class II - III medical devices and knowledge of instrumentation used in orthopedic joint surgery, you will both manage and perform mechanical design functions and use your medical materials technology to develop complex designs for novel surgical products.
Position Responsibilities:
• Conceptualize, design and develop innovative new products including, but not limited to orthopedic implants, complex surgical instrumentation and minimally invasive delivery systems
• Design and detail new products using state of the art 3D CAD software;
• Utilize Design of Experiments to develop test procedures and execute biomechanical verification and validation testing
• Effectively collaborate with customers, surgeons and cross-functional product development teams
Qualifications:
· Bachelors degree in engineering discipline
· Strong manufacturing, quality, and regulatory background
· 3- 8 years of medical device design or product development experience with broad experience in orthopedic implants
· Proven full life-cycle experience in complex technology research and product development
· Experience with medical device manufacturing processes, mechanical design, and knowledge of medical materials technology and characteristics.
· Experience developing solutions to complex design issues in accordance with QSR principles (13285, QSR, ISO 9001 )
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John Pandes
Senior Staffing Consultant
Gilead Sciences, Inc.
O: (650) 522-5599
F: (650) 522-1820
Subject: Career Opportunity with Gilead Sciences - Director of Formulations Development
I am a recruiter with Gilead Sciences. We are currently recruiting for a Director to lead our small molecule formulations development group. This is a very lean and successful team that has broad range of responsibilities where they follow the compounds from research to commercialization.
~ Director, Formulations Development
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From: david.obad@
T David Obad
Managing Partner
NCompass Recruiting
415.738.7878 x104 - Office
415.738.7878 - Facsimile
866.949.7878 - Toll Free Date: Tue, 11 Aug 2009 18:18:48 -0700
Subject: NCompass | Sr. Process Development Engineer - South Bay
I just picked up a new Sr. Process Development Engineer position with a client of ours located in the South Bay. This medical device company develops and manufactures RF based devices.
Below is the job description.
Job Category:
Manufacturing Engineer
Position Title:
Sr. Process Development Engineer
Salary Range:
DOE
Location:
Bay Area (South Bay)
Desired Skills:
Description:
POSITION: Sr. Process Development Engineer
DEPT: Manufacturing/Operations
REPORTS TO: Manufacturing/Operations Manager
LOCATION: South Bay
STATUS: Public
Summary: Design, Develop, Implement and Maintain Manufacturing Processes for assigned company lines of products (devices).
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)
-
Responsible for developing and implementing new processes on new
products and be the M.E. representative on development teams for
designing, developing, implementing, and maintaining assembly, test,
and packaging processes. Ensures that time lines, cost and quality
expectations are met.
- Develop new techniques for assembly and
test, including test fixtures, with DOE and validating new processes,
evaluate failure data from field to find root cause and implement sound
engineering solutions.
- Responsible for training techs and
assemblers and supporting transfer of product into manufacturing
facilities. Provide accurate tracking and reporting on this activity.
- Provide continuous engineering support on assigned products to maintain and improve margin, performance and quality.
-
Work with R&D team leader to deliver acceptable documentation on
product (including but not limited to: Assembly and test fixtures,
Routers, MPI, Test methods, Drawings and Specs) in a timely manner.
-
Participate and Manage (as required) engineering builds, verification
and validation builds, and provide technical data/ report to the team
leader.
- Act as a team leader on projects assigned by the manager of Process Development.
-
Ensure compliance with company quality system and all relevant internal
procedures and policies (including but not limited to: ECN, NCR, CPR,
BOM, Router, MPI/ SOP).
- Work on cost reduction projects to
reduce material/ process costs by defining and implementing new
techniques and equipment/ fixtures for assembly and test. This may
require designing fixtures and implementing in manufacturing
facilities.
- Assist and lead product and process transfers to Costa Rica manufacturing facility.
Supervisory Responsibilities:
Techs and/ or clean room personnel as required
Qualifications:
To perform this job successfully, an individual must be able to perform
each essential duty satisfactorily. The requirements listed are
representative of the knowledge, skill, and/or ability required.
Education and/or Experience: Essential. B.S. or M.S. degree in Engineering. At least 5 years in related field
Desirable: Experience in medical and surgical devices, and implantable biomaterials.
Language Skills:
Excellent
communication skills, and problem solving skills. Ability to plan and
schedule multiple projects and tasks. Fluent in Spanish a plus.
Mathematical Skills:
Needed for engineering position
Reasoning Ability:
Need to be able to make rapid and sound decisions
Computer Skills:
Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works.
Other Skills and Abilities:
Be able to work with people at all levels of organization and understanding of MRP and document control software
Other Qualifications:
Assembly and test fixture designing skills
Willing to travel up to 15% of time
Physical
Demands: The physical demands described here are representative of
those that must be met by an employee to successfully perform the
functions of the job.
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Contact Lee at lee@
Continuous Improvement Engineer
This position is located in the San Francisco Bay area with a relatively young Cardiovascular start-up company that is in the late stages of product development. They are looking for a Senior engineer that specializes on the continuous improvement side of the business. This person will work on special projects and report directly to the VP of Operations to drive lean methodologies/six sigma practices/continuous improvement.
Requirements:
BS Mechanical Engineering
5-7 years of experience in the Medical device industry
Green belt certification (Black belt preferred)
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Position provided by person in network who works at Entelos.
Interested candidates should apply via or via the company website at
Dynamic Engineer- Entelos, Inc
Company Description
Entelos, Inc., headquartered in Foster City, California, is a life sciences company improving human health through predictive biosimulation. Using our proprietary PhysioLab® biosimulation technology, in silico disease models and a virtual patient approach, Entelos identifies and validates targets, develops biomarkers, improves the success rates of clinical trials, and helps bring therapeutics to market faster. Founded in 1996, we have evolved into the foremost expert in creating and using predictive model systems of health and disease in drug discovery and development. We integrate the empirical and investigative strengths of biology with the mathematical and systematic strengths of engineering. We are seeking engineers and applied mathematicians for positions on our In Silico Research and Development staff. The Dynamics Engineer works with scientists and other engineers to perform in silico research and development. He or she provides mathematical modeling expertise, helps develop complex mathematical models that meet the needs of pharmaceutical researchers, uses these models in research projects, identifies novel experiments that can be done to address major knowledge gaps, writes project proposals and reports, and makes technical presentations of their work.
Job Description
The ideal candidate will have:
• A Ph.D. or substantial experience in Engineering, Applied Mathematics, Physics, or a closely related field with a strong background in nonlinear dynamics and control theory.
• Substantial experience in developing and analyzing mathematical models of complex, real world problems.
• Experience with collaborative, multidisciplinary research projects.
• A strong interest in biology and modeling/engineering/math expertise.
• Very strong communication skills, both verbal and written, including technical writing and presentation.
• The ability to work independently in a diverse, cross-functional team environment.
• Biology background is desirable.
• Industry or post-graduate experience is desirable, preferably in pharmaceutical or life sciences field.
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The British Consulate in San Francisco is currently recruiting for a Life Science Business Development Associate. I copy the job description and requirements below. Resume and a cover letter with salary history should be submitted in a .doc (word) file format by August 24, 2009 to resumes.bcgsf@.uk.
To Apply:
Resume and a cover letter with salary history should be submitted in a .doc (word) file format by August 24, 2009 to resumes.bcgsf@.uk. Please note in the subject line of your email "Life Science BDA". Internal candidates should address their resumes through their Head of Group before applying.
Only successful candidates will be contacted. Please no phone calls. Due to the high volume of resumes we receive, we can not guarantee consideration of your application if the submission instructions are not properly followed.
The British Embassy Network is an equal opportunity employer, dedicated to a diverse workforce.
UK Trade & Investment USA
Business Development Associate
Life Sciences
San Francisco
Life Science Business Development Associate
The British Consulate-General in San Francisco has an opportunity for an energetic, self-motivated individual to join a team focused on fostering transatlantic business relations between the US and its top economic partner in Europe, the UK.
UK Trade & Investment (UKTI) is the United Kingdom Government’s international business development agency. UKTI USA is charged with assisting US companies looking to invest in the UK and with transatlantic trade development between the UK and the US. (See .uk & ).
Role of the job:
This position will work with the Vice Consul for Life Sciences (Pharmaceuticals, Biotech, Medical Devices, and Healthcare) in San Francisco. This role will be responsible for:
• Identifying potential investors considering setting up or expanding in the UK. Make initial contact with companies (cold calling), arrange meetings for Vice Consul, attend meetings as appropriate and draft reports (where appropriate).
• Building and maintaining knowledge of developments and trends in the Life Sciences sector.
• Assisting with the execution of networking receptions, events, informational seminars, and other initiatives designed to develop business between the US and the UK. Track and report outcomes of such events.
• Responding to information requests and enquiries, addressing the needs of US clients.
• Providing operational support. Arrange schedules, flights, and accommodations for outside meetings. Provide CRM input, e-filing, and spreadsheet tracking.
• Conducting sector specific research on behalf of UK companies and supporting the wider team on UK trade missions.
Required skills and experience
• 2-3 years minimum work experience. College graduate or equivalent experience.
• Proficiency in Word, Excel, Powerpoint, and Microsoft Office is essential. Experience of Customer Relationship Management (CRM) software an asset.
• Good telephone skills, including ability to 'cold call'.
• Excellent research and communication skills (written and oral).
• Highly motivated with excellent organisation skills. Must be able to prioritise, to multi-task and meet tight deadlines.
• Strong team player.
• Familiarity with the US and/or UK life science industry would be useful.
Under US State Department requirements, the Embassy may only employ, as non-diplomatic staff, persons who are US citizens, US Green Card holders or A Visa holders. If you hold a Visa other than an A Visa you are not currently eligible to work at the Embassy. All candidates will be subject to background checks and security clearance.
The British Embassy Network offers a competitive salary and a strong benefits package. This package includes medical, dental, vision, life, long term and short term disability insurance, a 401(k) retirement savings plan, generous vacation and leave time, and an enriching training package.
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Contact
Karen Penner
Clinical Recruiter
ASG, Inc.
601 Gateway Blvd., Suite 210
South San Francisco , CA 94080
Phone: (650) 871-5000 ext. 4
Fax: (650) 871-1207
e-mail: karen.penner@asg-
asg-
Principal Medical Writer—Union, NJ
Type of Position
6-month contract, W-2, no benefits, on site; job ID 4004
Position Overview
Will be responsible for the preparation of clinical documents for worldwide sub-missions to regulatory authorities and for leading medical writing teams assembled to support large projects. Will support Managers within Medical Communications by providing technical guidance to junior members of the department.
Responsibilities
• Independent preparation of clinical study reports, integrated clinical summaries, overviews, and other regulatory documents on investigational drugs in various stages of clinical development.
• Lead medical writing teams assembled for large projects, e.g. submissions; coordinate and direct work of internal or external medical writers assigned to the writing team.
• In conjunction with Director and MedCom Managers, will coordinate resource allocation and identify projects that exceed capacity of internal Medical Writing staff.
• Will serve as liaison between outside writing sources and will review documents prepared by those outside resources.
• Will serve as department's representative for assigned therapy team/working groups; and will participate in determining submission-level timelines.
• Will review, update and communicate the operational and functional procedures utilized by the department with regard to document creation, review, quality control and publishing/archiving.
• Will also serve as a technical expert for the department and represent the department in cross-functional decision making teams and committees.
Requirements
• An advanced degree in Life Sciences - PhD or PharmD preferred (ideally, university doctorate/PhD)
• 10-plus years in Pharmaceutical Research & Development, with at least 5 of those years in Senior-Level Medical Writing.
• Ideally, 5+ years industry experience
Compensation
$50 to $60 per hour
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Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
Tel: (650) 825-2932
Fax: (650) 825-2992
Email: rkhenais@
View my LinkedIn Profile
I hope this message finds the group well. I wanted to just put out the word on a couple of immediate openings I am offering with a Peninsula-area medical device company. I'm hoping to make some new connections in the group or see if fellow members can help me connect with colleagues who can benefit:
Quality Inspector
Medical device experience required along with typical hand tools (calipers, gages, rulers, optical measuring tools) and visual inspection under the microscope.
Validation Engineer
Mid to Sr. Level experienced in catheter manufacturing processes.
As a reminder, I specialize in the medical device industry so I'm open to speaking with anyone having any type of medical device industry background and who are interested in exploring opportunities. Resumes can be sent to rkhenais@
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Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
FAX: (510) 235-4482
e-mail: jim@
SENIOR DEVELOPMENT PROCESS ENGINEER
▪ RESPONSIBLE FOR DEVELOPING AND IMPLEMENTING NEW PROCESSES ON NEW PRODUCTS AND BE THE M.E. REPRESENTATIVE ON DEVELOPMENT TEAMS FOR DESIGNING, DEVELOPING, IMPLEMENTING, AND MAINTAINING ASSEMBLY, TEST, AND PACKAGING PROCESSES. ENSURES THAT TIME LINES, COST AND QUALITY EXPECTATIONS ARE MET.
▪ Develop new techniques for assembly and test, including test fixtures, with DOE and validating new processes, evaluate failure data from field to find root cause and implement sound engineering solutions.
▪ Responsible for training techs and assemblers and supporting transfer of product into manufacturing facilities. Provide accurate tracking and reporting on this activity.
▪ Provide continuous engineering support on assigned products to maintain and improve margin, performance and quality.
▪ Work with R&D team leader to deliver acceptable documentation on product (including but not limited to: Assembly and test fixtures, Routers, MPI, Test methods, Drawings and Specs) in a timely manner.
▪ Participate and Manage (as required) engineering builds, verification and validation builds, and provide technical data/ report to the team leader.
▪ Act as a team leader on projects assigned by the manager of Process Development.
▪ Ensure compliance with corporate quality system and all relevant internal procedures and policies (including but not limited to: ECN, NCR, CPR, BOM, Router, MPI/ SOP).
▪ Work on cost reduction projects to reduce material/ process costs by defining and implementing new techniques and equipment/ fixtures for assembly and test. This may require designing fixtures and implementing in manufacturing facilities.
▪ Assist and lead product and process transfers to Costa Rica manufacturing facility.
Education and/or Experience:
ℜ• B.S. or M.S. degree in Engineering. At least 5 years in related field
ℜ• Experience in medical and surgical devices, and implantable biomaterials.
ℜ• Excellent communication skills and problem solving skills. Ability to plan and schedule multiple projects and tasks. Fluent in Spanish a plus.
ℜ• Needed for engineering position
ℜ• Need to be able to make rapid and sound decisions
ℜ• Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works.
ℜ• Be able to work with people at all levels of organization and understanding of MRP and document control software
ℜ• Assembly and test fixture designing skills
ℜ• Willing to travel up to 15% of time
Tooling & fixture design and experience in 3-D modeling (Solidworks) is a plus. More important is that the person understands the difference between tools & fixtures that are used in small laboratory/pre-clinical builds versus high volume production.
Candidates must have experience working within a regulated industry environment. Initial focus will be on learning new corporate systems rather than (for example) the reasons for conducting verification and validation and routing engineering change orders.
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The following positions are available at the Medtronic Sunnyvale location (Kyphon) Go to the Medtronic career site to apply on line.
Clinical Prog Dir
Lab Supervisor
Prin Accountant
Prin Regulatory Affairs Spec
Prin Quality Engineer
Program Manager
Sr R&D Engineer
R&D Engineer
R&D Engineer
Sales Education Representative
Sales Education Representative
Sales Education Representative
Sales Education Representative
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If you meet the requirements, please send your resume directly to
Sarah Salukas
Medical Device Recruiting Specialist
THE KENSHO Group
sarah.salukas@ .
Global Project Manager
Ophthalmic Medical Devices
San Francisco Bay Area, CA
Our client is a medical device start-up developing an intraocular epiretinal radiation device intended for the treatment of the wet form of Age-Related Macular Degeneration (AMD). The Company has entered into a definitive clinical study to support filing for regulatory approval to market the product in the U.S.
Overview:
This position will encompass the overall management of domestic and/or international medical device projects including budgeting, timeline adherence, internal and external communications, and project deliverables. The Global Clinical Project Manager will interact with operations, marketing, and finance to ensure the successful relay of clinical trial data to further enhance the value of The Company’s medical devices.
Responsibilities:
§ Provide leadership for study start-up, enrollment, and follow-up activities
§ Mentor, train junior team members
§ Develop study documents including case report forms, logs, and educational materials
§ Provide a central point of study communication for company, extended study team and senior management
§ Facilitate study progression by overseeing study activities, including internal and CRO activities
§ Ensure the study is tracking to study specific patient accrual milestones
§ Ensure timely data collection, entry and processing
§ Facilitate submissions of imaging to central reading centers
Requirements:
§ BS in biological sciences or related field and/or 5-10+ years clinical development experience in biotech/pharmaceutical industry setting required
§ Management experience including outsourcing to CROs
§ Excellent organizational and planning skills
§ Experienced in management of investigational sites is essential
§ Strong working knowledge of Good Clinical Practice required
§ Experience running global clinical trials preferred
§ Experience in the ophthalmic device, pharmaceutical or biotech industries is required
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Regulatory Affairs Manager
Innovative Cardiac Devices
San Francisco Bay Area
Our Client designs, develops, manufactures and markets innovative devices to enable
repair of cardiac valves. These devices are intended to reduce the risks, trauma and cost associated with current open-heart surgical options.
Summary:
The Regulatory Affairs Manager will lead the team of Regulatory Affairs personnel in preparation of EU submissions and preparation of pre-market submissions to the FDA including 510(k), IDE, PMA and PMA supplements in accordance with FDA regulations and guidelines. He or she will also develop personnel resources to facilitate more efficient preparation of FDA / EU submissions and personal growth
Responsibilities:
• Provide regulatory support and guidance to project teams and regulatory staff.
• Mentor all members of Regulatory Affairs staff to ensure personal growth and establishment of sound company resources.
• Prepare, manage, and submit FDA and European submissions for approval and ensure compliance with all US and international regulatory requirements.
• Review, provide feedback and approve design and manufacturing changes, nonconforming materials reports, rework orders, test protocols and reports to ensure regulatory compliance with FDCA, MDD and applicable standards, and determine filing requirements.
• Assist the Clinical department in creating submission strategies, developing and reviewing protocols.
• Work with upper management to develop business strategies to reduce time to market and ensure compliance with FDA regulations.
Requirements:
• Bachelor’s Degree in Science, Engineering or equivalent required
• Master’s degree in related discipline is desirable.
• Must have 6-10 years Regulatory Affairs experience preparing submissions for Class III US & EU medical devices.
• Two to three years experience leading projects or teams
• Positive attitude and willingness to work on a team.
• Ability to work independently and as a team leader.
• Technical writing experience desirable.
• Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems.
• Excellent communication skills and the ability to work with all levels of the Company.
• Strong organizational skills, attention to detail and ability to multi-task.
• ___________________________________________________________________________________
Director of Clinical Affairs
Ophthalmic Medical Devices, San Francisco Bay Area
A venture funded medical device company developing an intraocular device intended for the treatment of the wet form of Age-related Macular Degeneration (AMD). Wet AMD is the most progressive form of AMD in which neovascular growth from the underlying vascular system invades the retina and may also leak blood and fluid throughout the tissue layers of the retina. These disruptions cause damage to the macula and quickly leading to loss of central vision. Wet AMD is the leading cause of blindness in the elderly in the US with approximately 400,000 new Wet-AMD cases annually and a prevalence of approximately 1.5 million patients.
The Company has successfully completed two rounds of financing with premier venture capital investors in the medical device sector. With innovative products addressing a very large market opportunity and solid financial backing, this growing company is well positioned to pioneer treatment of AMD patients.
Summary:
Reporting to the Executive Director, Clinical and Medical Affairs, this individual shall manage all aspects of complex multi-site clinical studies. This management position includes the supervision of Global Project Managers in the qualification of clinical investigators, clinical sites, and the overall management of these projects in various phases of development, including monitoring of study activity to ensure they are conducted in a compliant, timely and effective manner. This individual shall lead in providing clinical and scientific support to health care professionals at the company’s clinical sites.
Responsibilities:
Consults with management to help formulate and implement proactive clinical regulatory compliance strategies and controls
Assists in the preparation of clinical protocols, instructions for use, case report forms, informed consents, and other required documents for clinical studies
Manage the approved clinical budget to ensure that expenses are monitored in accordance with the plan
Reviews clinical compliance assessments of audit findings and approves appropriate reports and monitors management following activities
Reviews and monitors required corrective actions
Maintains accurate and timely sponsor/site correspondence and communication.
Prepares and presents project progress reports to keep company management and clinical staff informed
Assists in preparation of the clinical sections of regulatory submissions and international registration packages
Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
Specific Job Functions:
Manage Global Project Managers and all aspects of multi-center clinical trials in accordance with federal regulations, corporate and departmental policies and procedures, department and corporate goals (timelines, budgets, etc.) including, but not limited to:
Development of protocol and all supporting documents (contracts, informed consent, case report forms, investigator binders, etc.)
Coordination of all activities with Contract Research Organizations (data management, monitoring, core labs, etc.) including selection, execution of contracts, ongoing support during study enrollment and follow-up, and preparation of reports
Coordination of site start-up activities including site selection, site qualification, site training, execution of contracts, shipment of investigational devices, and collection of regulatory documents
Coordination of ongoing study activities including device inventory, site maintenance, enrollment status, patient follow-up, adverse events, site payments, and data collection
Coordination of study close-out activities including return of investigational devices and preparation of reports
Maintenance of study status logs
Management of internal data management activities
Communication to upper management regarding status of studies, including identification of any issues
Oversight of internal study coordinators and administrators
Collaboration with the Regulatory Department in preparation of clinical sections of IDEs, PMAs, annual reports, and miscellaneous clinical reports, as needed
Assist with study budget development
Training of new departmental personnel
Keeping up to date on products and procedures
Physical Requirements:
Experience in hospital and standard office environment
Global Travel will be required at times up to 25-50% of the time
Minimum Qualifications, Education and Work Experience:
BS in biological or health science, preferable MS, PhD, MD or advanced degree
At least 3 years clinical research experience in the medical products, drug, or health care industry, preferably medical device industry and cardiovascular therapeutic area
Experience in the Ophthalmic Device, Pharmaceutical, or Biotech Industry
Strong verbal and written communication skills
Exceptional attention to detail is critical
Working knowledge of medical terminology, anatomy, physiology & biological systems
Understanding of how medical devices are used in the clinical setting
Working knowledge of federal regulations regarding Good Clinical Practice (GCPs)
Basic understanding of biostatistical principles
Ability to read and interpret scientific/clinical data presentations (charts, graphs, data tables, etc.)
Excellent interpersonal management skills, both internal and external
High level of professionalism and poise in a variety of business situations
Good judgment with the ability to think and react spontaneously
Preferred Qualifications, Education and Work Experience:
Knowledge of FDA regulatory requirements and ICH guidelines
Experience working with ophthalmic devices in a surgical environment
Experience working with radiation devices a plus
Working knowledge of current FDA Quality Systems Regulation, ISO 13485:2003, CMDR and the EU Medical Device Directive required
2+ years supervisory experience
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If interested, please submit your resume to moe@ .
Senior Manufacturing Manager, Sunnyvale
Reports To: Director of Lab Operations
Department: Operations
The Sr. Manufacturing Manager will be responsible for handling the daily operational issues. The manager will work with the Director of Lab Operations to develop long term solutions to improve productivity and build best practices designed to create an efficient process.
Responsibilities:
• Review processing schedules and production orders to make decisions concerning inventory requirements, staffing requirements, work procedures, and duty assignments, considering budgetary limitations and time constraints.
• Provide tactical direction to teams working to meet their daily production goals & milestones.
• Engage in problem solving in complex situations and process improvements in streamlining work processes.
• Review operations and confer with technical or administrative staff to resolve production or processing problems.
• Actively manage the performance of team members including writing and delivering performance appraisals and taking disciplinary action when warranted.
• Ensure that team members are cross-trained.
• Actively coach team in work scheduling/planning, peer appraisals, and team interviewing.
• Manage the implementation of lean manufacturing.
• Manage and maintain the production control procedures / SPC.
• Identify and implement improvements to reduce costs, cycle time and inventory levels.
Qualifications:
• 5+ years experience managing and leading people in a GLP / GMP manufacturing environment.
• Bachelor of Science degree in biology or chemical engineering required.
• Possess strong leadership and interpersonal skills, with the proven ability to teach and coach individuals from diverse backgrounds with varying language and technical skills.
• Must have experience leading project teams and implementing lean manufacturing systems and manufacturing monitoring / control systems.
• Familiar working within CLIA, GLP, ISO 13485, 21 CFR 820 manufacturing environments.
• Must be PC literate and have a strong knowledge of planning systems/approaches and measurement tools.
• Develop and implement production tracking and quality control systems, analyzing production, quality control, maintenance, and other operational reports, to detect production problems.
• Must have excellent verbal and written communication skills.
• Coordinate with HR on staffing and development
• Responsible for the safety of all direct reports.
• Responsible for anything related to housekeeping in production area.
• Responsible for product quality.
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Packaging jobs online—the following are highlighted on the packaging website this week. You can have jobs emailed to you. Go to website to register to have jobs emailed to you! Its free. Go to
|Job: Flexo Plate Sales |
|Location: HQ Atlanta, AN |
|Category: Food |
|Function: Field Service |
|Employer: Asahi Photoproducts |
|Description: We are a world leader in photopolymer printing plates, currently looking for Professional Sales Representatives to join its U.S. |
|business team. ... |
|Job: Graphic Designer |
|Location: Waco, TX |
|Category: Package materials supplier |
|Function: Package Design/Brand Mgmt. |
|Employer: Packaging Corporation of America |
|Description: PCA is a large, integrated packaging company located in Waco, TX. Ideal candidate should have a min. of 3 yrs experience in graphic |
|design. Degree in... |
|Job: SALES & MARKETING MANAGER |
|Location: Livermore, CA |
|Category: Package materials supplier |
|Function: Sales/Marketing/Biz Dev. |
|Employer: Packaging Innovators Corporation |
|Description: Develop a business plan and sales strategy for the market that ensures attainment of company sales goals and profitability; |
|responsible for... |
|Job: R&D Manager |
|Location: Buffalo, NY |
|Category: Food |
|Function: Package Development Eng. |
|Employer: Multisorb Technologies |
|Description: Working in a fast-paced, solutions-oriented environment, will be responsible for leading and directing development efforts for |
|Multisorb Technologies... |
|Job: Global Innovations Packaging Engineer |
|Location: Salinas, CA |
|Category: Food |
|Function: Package Development Eng. |
|Employer: Chiquita Brands International |
|Description: Develops improved packaging for new and existing product lines, and line extensions. Project work encompasses both short and |
|long-range developments.... |
|Job: Regional Sales Manager: Home-based |
|Location: Mid-Atlantic, NJ |
|Category: Package materials supplier |
|Function: Sales/Marketing/Biz Dev. |
|Employer: MJ Lupidi & Associates, Inc |
|Description: Well-established and growing Rigid Packaging converter providing packaging products seeking a Sales guru with the following |
|experience: *... |
|Job: Packaging Development Engineer |
|Location: Salt Lake city, UT |
|Category: Healthcare |
|Function: Package Development Eng. |
|Employer: Cephalon, Inc |
|Description: We are seeking a Packaging Development Engineer to work in our Packaging Technology Department. Successful candidates will champion |
|the introduction... |
|Job: Procurement Director-Packaging & PMO/COE |
|Location: Alpharetta, GA |
|Category: Food |
|Function: Procurement/Sourcing |
|Employer: CPG World |
|Description: As a member of the GSS leadership Procurement Directors are expected to provide both technical and strategic leadership to |
|multi-functional sourcing... |
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Other Information for Those in Transition
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Upcoming Bioscience Business and Marketing Courses in the fall at UCSC Extension at the new location in Santa Clara near intersection of 101 and Bowers…please help us promote these courses beyond those who have taken them already. There’s little information about these courses developed specifically for working professionals in the life science industry. These two days of intensive classroom work followed by 2 months of work done at student’s home location allows for participants who come from outside the Bay Area on business and add on two days and take a top rated course from experts in the field at an affordable price.
October 8-9: BIOSCIENCE BUSINESS AND MARKETING ESSENTIALS
The bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social and political challenges impose constraints that impact every aspect of the business. This course helps participants gain: a practical understanding of the bioscience industry landscape, key business drivers and challenges; insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and hands-on experience implementing important bioscience business processes that are essential to success within the industry. Presented by UCSC Extension in Silicon Valley, Santa Clara, CA. For more information: See ucsc-extension.edu/biobusiness.
December 3-4, BIOSCIENCE BUSINESS DEVELOPMENT: BUILDING VALUE
UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev
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Biotech Bay Career Fair, Tuesday Afternoon and Early Evening, Oct. 13, 2009
Event: Biotech Bay Career Fair
Location: San Francisco Airport Marriott
Date and Time: Tuesday, October 13, 2009; 2pm to 7pm
Click here for directions
Register at
Event Description
Positions in Biotech * Pharmaceutical * Medical Device & Diagnostics
Looking for a new job? Networking with industry peers in an ever-changing work environment?
Attend the Biotech Bay Career Fair!
Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay area.
Who should attend?
Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. Just register by clicking the button below.
(Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)
What types of positions are available?
Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.
What companies will be there?
Scroll to the bottom of the pages to see a list of exhibiting companies. Take the time to research what each company is recruiting for to see if you are a match. Most companies will be from the Bay area, but some will travel from other regions to attract top talent! If you can’t make it on event day, you can still pre-register online to allow exhibiting companies to view your resume and contact you outside of the career fair.
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Job Sites
The most known site for career and job listings is which focuses on biotech and pharma.
A newer website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled at
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
I’ve just received information on another new site with sole focus on medical devices and most in the Bay Area is I’m told they had 97 placements last year. Check this one out and let me know if you have good results.
You can look up pharmaceutical jobs in your area by zip code at . They include all functions in pharmaceutical companies.
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Other Helps
I received Biotech Ink Insider from Susan Caldwell, a local medical writer. She always has great insights as well as jobs at times to share. I’ve pasted in some videos mentioned by Susan that might be of interest for your job search:
Writing a Resume: When seeking a job, the resume is of considerable importance--it's your calling card and door opener. Here's a video that helps you create the right resume and minimizing the stress while you do it. Includes ten rules for how to approach your resume, interview, and job search. Very good basic advice.
Writing Your Resume Cover Letter: Same instructor as for Writing a Resume (above). Gives good basic advice on how to craft your cover letter and get the job interview you seek.
The Art of Medical Writing: Short video on the Masters in Medical Writing program at the University of Philadelphia, the only such training program in the world.
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Susan Caldwell wrote an article regarding writing a resume as well.
10 Tips for Creating a Door-Opening Resume
by Susan E Caldwell
If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers.
As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:
1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database.
Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance:
Introduction or Career Goal
Summary
Work History or Professional Accomplishments (if candidate has work history)
Academic Background
Skills
Honors and Awards
Publications
There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections.
When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization.
2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.
3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume.
4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies.
5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.
6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice.
The remaining points in this article address issues within your resume's sections:
7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.
8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.)
A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.
As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history.
9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.
10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers.
Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.
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About the Author
Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.
You can email Susan at caldwell@, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved.
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Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing.
As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
1.
2.
3.
4.
5.
6.
7.
8.
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See free downloadable annual Salary Survey from Contract Pharma at
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Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, , published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at .
This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search () and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.
The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon.
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These job postings are listed on my blog accessed at along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@ if they wish to receive these mailings directly.
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In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.