Jobs Posted through July 4, 2008
Jobs Posted through July 10, 2008
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This is Andrew Youngelson, Healthcare Technology Recruitment Partner from Key Recruit, Inc.
Andrew Youngelson
Key Recruit Inc.
andrewy@
I have a job opportunity you might be interested in---see below.
Thanks in advance for passing the opportunity along.
Please Indicate by job ID which you are interested in!
Director, Scientific and Regulatory Affairs
Date Posted: 7/1/2008
Job Id: 1631
Company: We are a privately owned specialty pharmaceutical company.
Our focus is on advanced injectable drug delivery. Our distinctive class of products delivers therapeutic levels of drugs to patients for periods ranging from one week up to one year with a single intramuscular or subcutaneous injection. We are currently using our patented technology to develop a portfolio of proprietary products in an array of therapeutic areas including but not limited to oncology, dermatology and ophthalmology.
Location: Ohio
Reports To: CEO
Salary: 140-170k Commensurate with experience.
Education: Preferred Ph.D. in Chemistry, or a closely related
scientific discipline.
Requirements: Requires ten (10) years of recent experience in the US
pharmaceutical drug development and manufacturing industry with emphasis on clinical and non-clinical disciplines subject to multiple aspects of FDA laws and regulations. Experience must include at least five (5) years in a management-level position managing, motivating and coordinating multi-disciplinary functions to accomplish successful registration of new drugs, and involving regulatory filings and submissions related to Company's strategic focus, preferably at a mainstream pharmaceutical company. An extensive background in IND, NDA and ANDA preparation and documentation is essential, as well as regulations and policies of labeling, marketing and advertising of products. Expert knowledge of CMC content and requirements, and cGMP regulations is required. Extensive FDA communication experience is critical. Requires significant experience, both internal and external, in collaborating with business development, pilot plant and manufacturing to bring new product to market. Experience in an international drug development setting is a plus. Experience in licensing (in and out) and business development in the pharmaceutical industry preferred. Must have expert knowledge of regulatory requirements and a complete and thorough understanding of the clinical, non-clinical, labeling and promotional/marketing aspects of the drug development process, and also with FDA and applicable international regulations, as they apply to new drug development and registration maintenance activities. Must have demonstrated ability to direct the Company's regulatory affairs efforts. Ability to manage multiple projects and deliver results on timelines that support Company objectives is critical. Knowledge of sustained release technology is desirable. Must be skilled in analyzing information and data, implementing procedure/methods, developing SOP's, and decision-making and problem solving. Effective communication, and project and time management are essential. Computer literacy and documentation/report writing are necessities. Level of required skills and abilities is exceptionally high, and includes fulfilling business goals and objectives for area of responsibility and supervising, developing, leading and inspiring a groupwith scientific and technical expertise.
Duties: Directly supervises Regulatory Affairs positions and leads
CMC activities in R & D. Also serves in a coordinating capacity for regulatory submissions and filings, and in response to FDA findings and requests. The incumbent is responsible for planning, organizing, directing, and/or controlling the effective operation and productive results of all Scientific and Regulatory Affairs activities. Makes recommendations in areas involving legal matters, and in complex employment issues. Makes decisions in areas of staff selection and routine employment matters. Is responsible for performance management and review of subordinates. Nature of departments under incumbents direction is primarily technically oriented and complex.
Usually works with and/or creates information that is restricted by the Company or legal/regulatory requirements such as development projects, analytical test data, clinical trial data, proprietary information regarding chemical entities, intellectual property, manufactured product information, business plans, budget information, personnel information. Provides valuable input for budgetary matters and adheres to approved budgets. Has considerable discretionary spending authority in accordance with Company policy. Financial matters beyond the incumbents authority are directed to the Chairman. There is extensive responsibility for making decisions that typically affect the operation of Regulatory Affairs and the R&D department, and usually affects the operation of other individuals, groups, or another department, such as when coordinating Regulatory Affairs matters with other departments. Impact of decisions is extensive even though supervision is present to review results. Work is widely varied involving many complex and significant variables. Independent judgment is required to recommend departmental objectives, design and evaluate new approaches to problem solving, assess changing facts or conditions, and assure compliance with Company policy and legal/regulatory requirements.
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Principal Research Scientist II - Study Toxicology Director
Date Posted: 6/27/2008
Job Id: 1630
Company: We are a research-driven pharmaceutical company. We have a
long history of ground-breaking developments in pharmaceuticals and biotechnology. We lead the world in the discovery and development, manufacturing and marketing of vaccines and pharmaceuticals. We improve the lives of millions of people around the world with our exceptional products. And new, innovative medicines are on the way. We bring products to the people who need them around the world.
Location: Upstate New York
Reports To: Director of Toxicology
Salary: 95-146K Commensurate with experience.
Education: Phd.
Requirements: Training in Good Laboratory Practices, Drug Safety
Evaluation Standard Operating Procedures, pharmaceutical industry or other aspects of toxicology studies. Experience in conducting toxicology studies.
Good human relations and writing skills necessary. Ability to motivate and direct employees, understanding of Good Laboratory Practices and Standard Operating Procedures.
Duties: The Toxicology Study Director will plan, direct, and
interpret safety studies on new drug candidates taking overall responsibility for these studies in accordance with GLP and other regulatory guidelines. Duties include overseeing, coordinating, and participating in the preparation of technical regulatory documents relating to those studies.
He/she will represent Drug Safety on project teams and facilitate communication of safety issues to and from project team members. Works with general supervision and need for consultation with management on day-to-day operations. 1. As GLP Study Director, plan direct and interpret short and long term toxicology studies in laboratory animals on new drug candidates.
Serve as study team leader and ensure coordination of all parties contributing to study data (study team members) including Study Toxicologist, Study Supervisor, and Study Technician. Related responsibilities include: a. Prepare study designs for routine and special studies. Oversee the drafting of protocol outlines, study protocols, IACUC documents and other written materials consistent with the study designs approved by reviewing committees (e.g., PRC). b. Monitor the technical conduct of studies for adherence to protocol and for development of toxicologic effects. Report regularly to management on the progress of these studies. c. Direct the preparation of study reports, ensuring appropriate quality control procedures are used and effective and that schedule is maintained. Provide interpretation of results and integrate information provided by other groups (e.g., pathology and drug metabolism). 2. Perform similar oversight duties as Principal Investigator for studies directed by Drug Metabolism personnel. 3. Monitor designated studies at contract laboratories, serving as their principal liaison and communicating developments to Wyeth Research management, as appropriate. 4. Provide summaries of safety information for inclusion in submissions to regulatory agencies, assuring accuracy and readability within format guidelines. Work closely with document preparation staff to review and edit the overall documents and to integrate contributions from other groups (e.g., reproductive toxicology, drug metabolism). 5. Represent Drug Safety on multi-disciplinary project teams. 6. Participate in Drug Safety and Metabolism Protocol Review Committee, Project Review and other meetings involving multi-disciplinary review of drug safety data and department policy. Prepare and update SOPs. 7. Keep abreast of major developments in drug safety, recommending implementation of appropriate methods or acquisition of appropriate instrumentation.
As always thanks for passing on!
Visit to view other openings.
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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@
Quality Engineer
Summary: Implement, support, and sustain elements of quality system through procedure generation, training, auditing, and technical support. The quality engineer serves as a key resource for ISO, EN, MDD, and QSR requirements.
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)
▪ Provide leadership and support to new product development project (PDP) teams.
▪ Generate/approve validation studies, capability studies, FMEA/Hazard analysis. Responsible for compliance to design control activities, environmental monitoring, sterilization validation, and shelf life requirements.
▪ Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers.
▪ Support manufacturing operations in Costa Rica and provide expertise in statistical process control, min/max studies, and evaluation of control charts.
▪ Ensure that compliance to cGMP and EN/ISO 13485/MDD requirements are maintained.
▪ Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
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:
• Requires a team player with a bachelor’s degree in engineering or life sciences and a minimum three years experience in the medical device industry.
• Must be able to make decisions related to product quality and release of products.
• Requires ability to assess current practice with external standards, guidance, and regulations. Must be able to provide and implement solutions to quality problems.
• Requires the ability to understand the impact of GMP’s, ISO 13485, and MDD requirements on new products.
• Must have effective written/oral communication skills.
• MS Office, Excel, Statistical software
• CQE (ASQC) certification preferred
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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 Product Manager
This position is responsible for developing promotional materials and programs that will help meet the sales objectives for their product line. The Senior Product Manager should use communications with customers and the sales force to reinforce a Company commitment and focus on customer satisfaction. The Senior Product Manager should work closely with the field sales representatives to support and enhance current products.
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned):
♣ Develop sales materials and track promotional programs. Manage the current product lines. Analyze sales data and compile competitive information. Interface with R&D to develop line extensions and product improvements.
♣ Provide timely and effective communications with the direct and indirect sales force.
♣ Ensure that the sales force is trained on current products, developing promotional materials and programs that will help meet the sales objectives for their product line.
♣ Assist the sales efforts by creating useful information and materials to increase the usage of the company products.
♣ Work with vendors to insure that materials are produced on time and within budget.
♣ Provide accurate sales forecasts for manufacturing. Initiate ECNs to update and maintain the current products.
♣ Provide timely information concerning sales trends and performance to budget.
♣ Use data to effectively respond to market changes.
♣ Provide timely marketing input and assist in the R&D efforts.
♣ Provide product information and training for the sales force.
♣ Provide regular communications to the sales force, which will increase their knowledge and selling effectiveness.
♣ Make decisions concerning the format and design of product support materials.
♣ Work with the Director of Marketing to develop marketing plans and strategic objectives.
♣ Use strong communication and analytical skills to provide sales trends and forecasts.
♣ Develop marketing programs that add value to our products and improve customer satisfaction and increase sales.
♣ Responsible for implementing marketing and sales strategic plans.
♣ Will be responsible for providing marketing input for product enhancements and line extensions.
♣ Act as the main in-house contact to provide technical information and support for the sales force.
♣ Utilize knowledge gained from experiences and input from the Rapid Rhino community to develop sales programs and support materials to increase the sales of our current products.
Qualifications:
• Requires a BA or BS degree (MBA a plus)
• 5+ years of medical sales and marketing experience.
• Must possess in-depth understanding of how products are used and of factors that can influence the buying decision.
• Must have a good understanding of the medical environment to effectively respond to market concerns and provide technical support for company products.
• Strong influence adaptability, management, negotiation, leadership, motivational, and assertiveness skills.
• Requires excellent verbal and written communication skills.
• Sound ability to think creatively and adapt thinking and actions to new directions.
• Strong presentation skills.
• Strong attention to detail and follow-through skills.
• A proven track record of consistently exceeding goals, and successful product launch experience also required.
• Experience with the regulatory process (FDA, UL, CE, etc.) is preferred.
• Intimate knowledge of product development and marketing.
• General knowledge of finance in relation to product development management.
• Must be able to work with the field sales force, as well as communicate well with clinical thought leaders is a must.
• Experience working with external vendors and design companies to produce written materials, and ability to work well with internal personnel from all departments is essential in order to successfully manage the product line.
• International medical marketing experience is a plus.
• Must have excellent verbal and written communication skills and knowledge of office equipment and word processing.
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Contact: Neil Gregory | Executive Recruiter | Battelle The Business of Innovation | o 614.424.4420 | f 614.458.4420; ♫
gregoryd@
Battelle is a world renowned R&D organization, providing innovative scientific and engineering solutions to government and commercial clients. With over 100 offices in domestic and international locations, we conduct over $4 billion in annual research and manage more than 20,000 staff members worldwide. Position in MD area.
The Health and Life Sciences Global Business is seeking candidates for the Relationship Manager of Battelle's work with the National Institutes of Health. Current work includes institutes such as the National Institute of Allergy and Infectious Disease, National Institute of Child Health and Human Development, and the National Toxicology Program. Incumbent will be responsible for growing work in the and additional institutes.
Position Summary
Individual will be responsible for strategic business development within the National Institutes of Health. This includes developing and implementing business and marketing plans for components of the National Institutes of Health, developing new business in a number of institutes, managing financial performance, and leading substantial proposals. Incumbent will manage communication with clients to assure client satisfaction with current work.
Position Responsibilities
•Develop and implement strategy for expanding Battelle business with NIH, DHHS, OS
•Manage business development budget
•Determine viability of business opportunities and make bid/no bid decisions on behalf of the Health and Life Sciences business
•Partner with internal groups to evaluate, author and oversee proposal submissions
•Ensure the quality of proposal submissions to potential clients within NIH, DHHS, OS
•Act as ombudsman to ensure client’s technical expectations are being met
•Educate and advise Product Line Managers regarding NIH technical needs and work with them to develop those capabilities within Battelle
•Candidate will serve as the primary link between our NIH clients and Battelle product lines. Major responsibilities include implementing strategy, managing business development, budgeting, ensuring the quality of Battelle's work
•Reports directly to the Vice President, Health Sciences, Health and Life Sciences Global Business
·Establish effective working relationships with NIH clients, meet with existing and potential clients to discuss client needs and how Battelle can meet them, develop strategies to grow the business.
Required Qualifications
•Doctoral degree (PhD, DrPH, MD/MPH, DVM, etc) in a field related to public health research such as epidemiology, biostatistics, health services research, chemistry, biology, or other lab or clinical sciences.
•Minimum of 10 years post-doctoral level experience in related field.
•5+ years of demonstrated experience marketing research programs on Department of Health and Human Services activities, including the National Institutes of Health
•Demonstrated understanding of government-sponsored research in the U.S., especially related to the National Institutes of Health
•Understanding of the National Institutes of Health grants and contracting processes, including project development and proposal writing.
•Strong track record in obtaining or reviewing proposals for government sponsored research
•Outstanding oral and written communication skills
In return for your valued contributions, Battelle offers competitive compensation and a generous benefits program.
Battelle is an Affirmative Action/Equal Opportunity Employer (EOE)M/F/D/V.
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Qualified candidates please reply to:
Gil Paz
gpaz@
tel: 925-242-1010 x 102
Below you will find our current monthly update on positions we are working on in medical device here in the SF bay area. You will notice we have a few new positions located in Southern California , which are highlighted below. Please feel free to pass this along if you know anyone that might be interested in taking a look. If you have any questions, you are welcome to get in touch anytime. Thanks in advance and hope this finds you well! Kind regards, Gil
Most Urgent Positions:
▪ Advanced Manufacturing Engineer
▪ Director of Quality
▪ Dir/VP of Product Development
▪ Project Manager
▪ Director of Marketing
Southern California Positions:
▪ Director of Quality
▪ Product Manager
▪ Marketing Manager
R&D, MANUFACTURING & OPERATIONS ROLES
Director/VP of Product Development
▪ MS or BS in Mechanical Engineering, Material Science, higher degree a plus
▪ 15+ years of medical device experience
▪ Stent/Catheter and delivery system design process
▪ Biodegradable Polymer experience a major plus
Project Manager
▪ BS degree and a minimum of 8 years relevant work experience
▪ 5+ years of project management experience in medical device
▪ Project Management certification is a plus
▪ Strong conflict resolution and problem solving skills are a must
Package Engineering Manager
▪ BS or MS degree in Engineering
▪ 6+ years in related field and 2 years of management experience
▪ Experience in medical and surgical devices, and implantable biomaterials desireable
▪ Solidworks experience preferred
Senior Tooling Engineer
▪ BS degree in Engineering, Mechanical preferred
▪ 4-7 years in related field, or 3-5 years with an MS
▪ 2 years work experience with Equipment, Fixture and Tool design
▪ Good knowledge of Solidworks
Sr. Electronics Engineer
▪ MS or BS in Electrical Engineering or related study
▪ 7+ years of related experience in embedded control system design and debugging
▪ Knowledge of embedded, microprocessor based control design
▪ Expertise in Xilinx, Verilog and Altium
Sr. Electrical Engineer
♣ BSEE
♣ 10+ years of experience in electrical engineering
♣ demonstrated exceptional project leadership abilities
♣ medical device experience required (capital equipment would be ideal)
Advanced Manufacturing Engineer
▪ BS Engineering degree or equivalent
▪ 10+ years of medical device manufacturing and design experience
▪ Process Engineering experience
▪ Proficiency with CAD software (ideally Pro/E and AutoCAD)
Sr. Manufacturing Test Engineer
▪ BS in Electrical Engineering, Computer Science or related field
▪ 7+ years experience in manufacturing test engineering within a NPI environment
▪ 6 Sigma Black Belt and Demand Flow Technology a plus
Manufacturing Engineer
▪ BS degree in mechanical, electrical, chemical, materials or industrial engineering
▪ 3+ years experience in manufacturing environment
▪ Pro-E competency is desirable
Sr. Software Engineer
♣ BA/BS - Computer Science or related
♣ 10+ years of experience in software engineering
♣ Strong project management and people management skills
♣ medical device experience preferred
♣ Windows programming experience, .NET
♣ software design and validation experience
Sr. Software Engineer
♣ BSEE/BSCS plus 6 to 10 years experience the development of SW for embedded systems, and at least 3 years in medical devices
♣ Proficiency in C, C++, object oriented, and assembly language programming
♣ Proven track record of successful product development using a variety of design tools and prototyping techniques
♣ Basic knowledge of project planning and management use of PM software such as MS Project
Director of Human Resources
▪ BS and 15 years experience, which includes leadership and progressive organizations
▪ Experience in a manufacturing environment a must
▪ Medical device experience is preferred
▪ Working knowledge of Federal and California State Labor law
▪ Strategic and visionary yet hands-on to manage day to day assignments
SALES, MARKETING & BUSINESS DEVELOPMENT
Marketing Manager (So. Cal)
♣ Bachelor’s degree in business or marketing (MBA preferred)
♣ 3-7 years of product management experience
♣ Upstream & downstream experience required
♣ Endovascular medical device experience required
♣ Strength in branding and positioning – strong commercialization experience
Product Manager (So. Cal)
♣ BA/BS degree, MBA preferred
♣ 2+ years of Product Management experience
♣ medical device experience
Worldwide Director of Marketing
♣ BS degree in business or related field. MBA desired
♣ Experience with lifestyle medical products and female oriented products/services with consumer promotion is a big plus
♣ Experience in leading strategic and tactical planning
♣ Clinical manuscript management experience is a plus
Regional Sales Director – East Coast
♣ College degree required with MBA desired
♣ 3+ year’s successful management experience in the aesthetic experience
♣ Experience in capital equipment sales, preferably in the aesthetics market
♣ Excellent verbal and written communication and coaching skills
SVP of Marketing / Group Director
♣ 10+ years marketing experience - med device and/or bio-pharma experience required
♣ Advertising agency experience is required
♣ Brand strategy experience required
♣ BS in Management, MBA preferred
Account Supervisor
♣ Significant expertise in print, print buying and press checks, stock, coatings etc.
♣ Exceptional project management skills is a must
♣ Ideal candidate will be enthusiastic and a team player with a positive attitude
♣ Proven track record at previous advertising agencies
♣ Excellent with Creative Briefs and Strategic Proposals
♣ Understands Online, Video, TV, and Radio production
♣ Strong computer skills, i.e. Microsoft Office – Word, Excel & PPT
(Sr.) Product Manager
▪ BA/BS (MBA a plus)
▪ 2-5 years of medical device and marketing experience
▪ Product launch experience
▪ Travel required
▪ Cardiovascular OR ortho device experience preferred
REGULATORY, QUALITY & CLINICAL AFFAIRS
Director of Quality (So. Cal)
▪ BA/BS degree
▪ 8+ years experience in medical device
▪ Currently operating at a Sr. Manager/Director level
Quality Assurance Manager/Director
▪ MS or BS in Engineering and/or Science related field
▪ 10+ years of medical device experience
▪ Stent/Catheter experience
▪ Proven track record with FDA and notified body regulatory audits experience
Quality Engineering Manager
▪ Bachelors degree in engineering or Life Sciences
▪ 4+ years medical device experience
▪ 2+ years in management
▪ Ability to understand the impact of GMP’s, ISO 13485:2003, Canadian, Japanese and other international standards, and MDD requirements
Manager of Post Market Quality
▪ Bachelors degree in Engineering
▪ 5+ years experience in a medical device manufacturing environment
▪ 5+ years experience with complaint handling and investigation
▪ Written and verbal communication skills a must
Sr. Quality Engineer
▪ Minimum of BS/BA (MS preferred) degree in Engineering, Chemistry or Life Sciences
▪ 5+ years experience in medical device
▪ Thorough knowledge of cGMP, QSR, ISO/En, and FDA standards
▪ CQE (ASQ) and CRE (ASQ) certification a plus
Quality Engineer
▪ BS degree in Engineering
▪ 3+ years experience in medical device
▪ Requires the ability to understand impact of GMP’s,ISO 13485, and MDD requirements
▪ CQE (ASQC) certification preferred
Clinical Research Associate
▪ Bachelor's degree in scientific discipline
▪ 2+ years of clinical research studies experience
▪ Must have working knowledge of FDA and EU regulatory policies, procedures and requirements
▪ Knowledge of interventional procedures, physiology and associated medical terminology strongly preferred
▪ Travel up to 40%
Clinical Research Associate (3-6 month contract)
▪ Bachelor's degree
▪ 2+ years of clinical research experience in medical device
▪ 70% travel
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