Jobs Posted through July 4, 2008
Jobs That Crossed My Desk Through June 27, 2009
Contact the person whose information appears at the top of each listing. Individual listings by individual executive search recruiters are separated by string of stars. Multiple listings submitted by one recruiter are
separated by straight lines with contact information listed once above that group of jobs.
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Janet Jarboe
Jarboe & Associates
Serving Professionals Since 1997
1748 Clear Creek Court
Windsor, CO 80550
janetjarboe@
970-686-5899 (office)
970-689-2962 (cell)
Manager/ Associate Director of Analytical Development – New Jersey
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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Director, Regulatory Affairs - California (reports to Vice-President)
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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Research Scientist / Senior Research Scientist: Target Validation/ Mechanism-of-Action and Biomarker Development - California
This position will be critical for leading and advancing major projects at the company to facilitate the identification of novel monoclonal antibody therapeutics for cancer.
The qualified candidate will establish in vitro cell-based platforms for validating cancer targets, develop systems for exploring cellular phenotypes and molecular pathways of cancer, and evaluate their modulation by monoclonal antibody product candidates. The incumbent will have expertise in cancer biology, signal transduction pathways, cell biology, biochemistry, assay development and monoclonal antibodies. The candidate will be responsible for identifying key cellular functions and molecular components of cancer target pathways for evaluating monoclonal antibody activities and mechanisms-of-action. Additionally, the applicant will develop biomarker assays based on cellular or molecular discoveries that will be validated extensively in anti-tumor analyses. The incumbent will join an interdisciplinary team of scientists and research staff validating novel targets for selection of future therapeutic antibody candidate development. The position will involve both management and bench-level activities, as well as cross-functional interactions with research teams focused on target validation and reagent generation for program development.
Requirements
Candidate consideration requires a Ph.D. degree and 6+ years of experience in industry with a proven record in the required expertise and activities. Successful applicants will have strong written and oral communication skills, be self-motivated, demonstrate leadership and possess an exemplary record of research, as evidenced by publications and patents. Developmental opportunities include leading projects for therapeutic monoclonal antibody discovery, building new technology platforms and team leadership.
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Formulation Development Scientist – California
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.
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 - California
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 site 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.
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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Manager, Clinical Pharmacology -Illinois
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 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.
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 - Illinois
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.
1. 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 APERD 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 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 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.
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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Associate Director, Market Research & Intelligence
Reply to: (see message body)
Date: 2009-06-22, 10:05AM
Medarex Inc. is looking for an Associate Director of Market Research to support and lead both internal and external market analysis projects. This position will report to the senior director, Market Research and Intelligence and will also serve as a member of project teams
Responsibilities include, but are not limited to:
• Developing target product profiles for projects in a variety of indications.
• Helping to identify critical data to support clinical/commercialization decisions.
• Providing competitive data and intelligence quickly and concisely.
o Includes understanding current standard of care and potential future standard of care.
o Includes data analysis to summarize situation of competition in real time as data is released.
• Producing and maintaining forecasting and market models.
• Overseeing the use of third party consultants.
o For input on the market potential.
o For commercialization planning.
• Attending and reporting on industry meetings.
• Helping to put together advisory boards and to identify key opinion leaders.
Required skills/experience includes, but is not limited to:
• Strong knowledge of oncology marketplace with knowledge of autoimmune indications a plus.
• Familiarity with market research and marketing tools such as excel modeling, conjoint analysis, advisory boards, primary and secondary research methodologies, and web based research.
• Strong independence and leadership skills required; track record of honesty, integrity, and problem solving.
• Must be able to multitask with a high level of quality.
• Must have excellent communication skills including the ability to concisely summarize information and focus on critical issues.
• Should be available for travel 5-15% of the time.
• This position can be based in either our Milpitas, CA or Princeton, NJ offices.
• BA/BS required; MBA/MD/PhD a plus.
• 7+ years of experience in marketing/market research in the biotech/pharmaceutical industry or related consulting.
• Commercialization experience in oncology desired.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development, and potential commercialization of fully human antibody-based therapeutics to treat life- threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody products for itself and its partners. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. To apply, please visit our website at
• Principals only. Recruiters, please don't contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.
Original URL:
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Please send your resume to humanresources@.
Clinical Project Manager, Micrus Endovascular Corporation, San Jose
Essential Duties and Responsibilities:
Serve as a Project Manager for Clinical Research studies and principal contact person. Monitors and oversees the activities of contract monitors and Contract Research Organization (CRO) staff assigned to study sites. This Project Manager will help identify appropriate sites for trials, negotiate study budgets, support IRB/EC submissions, support study sites from qualification through study close-out, and mentor, train, and audit the performance of any monitors assigned to clinical research sites.
The Project Manager will conduct activities to ensure Clinical Research projects are in conformance with applicable regulations and Good Clinical Practice (GCP) guidelines.
Education and/or Experience:
• Bachelor's degree (B.S.) preferably in Biology, Nursing, Physiology, or similar scientific discipline and/or; 5 years related clinical research experience and/or training is required.
• Working knowledge of FDA and EU regulatory policies, procedures and requirements.
• Knowledge of interventional neuroradiology procedures, physiology, pathophysiology, and associated medical terminology strongly preferred.
Travel:
30% to 60% travel, domestic and international.
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If you have interest in this opportunity please reply with Word Doc resume to Mike Adkins (MAdkins@)
Our client is looking for an Environmental Health & Safety Manager. This position is based in the Oakland/ East Bay area. This person will develop and maintain programs for improved safety performance and regulatory compliance. They will also be the primary contact with regulatory agencies on all EH&S matters. Other responsibilities will include conducting environmental and safety training, provide reports, supporting HR, develop risk control methods and make appropriate recommendations. They will also be responsible for training all new employees. The emphasis will be on Health and Safety.
To be considered for an interview you must have the following experience/skills:
• 4 year degree in a science field, knowledge of Chemistry is a big plus
• 5-7 years experience in a health and safety role, please note this position does not have any direct reports
• Must have experience leading groups or teams
• Should have experience conducting emergency response teams, giving first aide, conducting evacuation drills, etc.
• Radiation safety experience is a big plus
Position Rewards include:
• Excellent comp package
• Advancement opportunities
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|Experienced Medical Writers |
|New York, New Jersey, Atlanta, and San Francisco |
| |
|My clients, both excellent Medical Communications companies in New York City are actively seeking experienced medical writers for full time |
|permanent opportunities. Experienced writers with Medical Education, Medical Communications or Pharmaceutical advertising writing experience are |
|desired. |
| |
|Qualified applicants must have the following: |
| |
|A PhD, MD, or Pharm D degree in a life sciences discipline |
| |
|2 years or more of industry experience preparing & writing (manuscripts, posters, educational programs, journal articles, executive summaries, |
|abstracts, power point, slide kits, review articles, etc) |
| |
|CNS and/or Oncology experience desired |
| |
|Experience in a variety of therapeutic areas a plus (Psychiatry, Oncology, Diabetes, Psychology, RA, Cardio, Neurology, etc) |
| |
|Salary depends upon experience. |
| |
|Please send a Word copy of your CV to alex@ for consideration. |
| |
|Alex Showers |
|Liberty Personnel Services |
|610-941-6300 ext 114 |
|alex@ |
|Senior Medical Writer Specialist |
| |
|i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions|
|that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership |
|and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed |
|customer expectations. |
| |
|As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and |
|commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 |
|Statprobe can provide. |
| |
|i3 Statprobe is currently seeking a home- or office-based Sr. Medical Writing Specialist to create clinical documents for use in regulatory |
|activities by client and affiliates when they respond to questions from health care providers. |
| |
|Responsibilities |
| |
|Develop clinical regulatory documents, including study reports, protocols, and investigator brochures |
| |
|Develop tables, charts, figures, and other display elements for clinical data |
| |
|Ensure document consistency and comprehension |
| |
|Manage timelines and milestones |
| |
|Lead or participate in meetings |
| |
|Coordinate quality reviews as needed |
| |
|Qualifications |
| |
|Bachelor's degree in life science or clinical field of study required; MS, MPH, PharmD, PhD, or other advanced life science degree preferred |
| |
|Extensive experience in writing clinical regulatory documents in a pharmaceutical, CRO, or freelance environment |
| |
|Knowledgeable of eCTD organization and preparation |
| |
|Thorough knowledge of relevant GCP, ICH, and FDA guidance documents |
| |
|Working knowledge of basic statistics with ability to analyze descriptive and numeric data and present these with clarity and accuracy |
| |
|Thorough knowledge of clinical research design and methodology |
| |
|Excellent organizational and planning skills |
| |
|Excellent proofreading, editing, and internet research skills |
| |
|Strong written and verbal communication skills |
| |
|Proficient in the use of Microsoft Office software, including Documentum, templates, styles, table formatting, and customized toolbars |
| |
|Proficient in the use of English grammar, punctuation, and spelling |
| |
|Experience writing manuscripts for medical/scientific publications is a plus |
|For immediate consideration, please email a copy of your resume to Jessica Warchal at Jessica.warchal@. |
| |
|Diversity creates a healthier atmosphere: equal opportunity employer: M/F/D/V |
| |
|UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. |
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Nancy Cody
Wirth & Associates
wirth@wirth-
Director, Development Quality - 011-06229-TWV
$130K
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. Has oversight and responsibility for Development Quality Engineering.
Qualifications:
Bachelors Degree in Business, Sciences, Engineering or related field, or any combination of academic education, professional training or work experience which demonstrates the ability to perform the duties of the position. Masters degree preferred.
Experience:
A minimum of 10 years experience with quality responsibility. Experience in either medical device and/or pharmaceutical products is required. Formal training in Quality Systems and Quality Engineering.
Must have working knowledge of European and US and international regulations and standards covering in vitro medical devices.
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Director, Sr. Regulatory - 02-06229-TWV
$150K.
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.
Qualifications:
Bachelors Degree in Business, Sciences, Engineering or related field. Masters preferred.
Experience:
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. Hands-on experience and scientific and technical background/training in regulatory submissions for in vitro diagnostic devices preferred.
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Partner
Standing Stone Partners, LLC
droth@]Dan Roth
1837 Normandy Way
Livermore, CA 94550
I am with Standing Stone Partners and we
are a full-service marketing consulting firm. We work with
early-to-mid-stage start-ups to assist with wrapping a business around their
technology. We are looking for an additional public/media relations
professional to work with us on a contract basis for one of our clients.
Would you send this forward and see if anyone is interested. If so, they
can contact me directly at droth@. If they would
send their interest as well as a resume, that'd be great.
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This posting is from Michelle Miller at AccessClosure. If you or someone you know is interested and qualified please send the resumes to HR@
TITLE: Senior Quality Control Technician
FLSA: Non- Exempt
SUMMARY/RESPONSIBILITIES:
SUMMARY: Provides technical support to Quality Assurance, Manufacturing and Engineering functions. Reviews materials and documents to assure acceptability of components and products.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Perform component and final product acceptance activities
Identify and report nonconforming materials
Oversee sterilization processing at the contract sterilizer
Submit materials to sterilizer and laboratories for revalidation activities
Perform engineering test protocols as required
Perform design verification testing
Obtain and file MSDS for chemicals
Label chemical materials as they arrive in the facility
Train new Inspectors/Technicians
EDUCATION/EXPERIENCE:
High school diploma required and some college or technical education preferred. Ability to perform basic mathematical functions.
Five to seven years experience in quality assurance and/or manufacturing in a manufacturing environment.
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To learn more about this opportunity, please click on the following link:
Senior Medical Device Analyst of Guidepoint Tracker: Job Description
The Guidepoint Tracker, a novel rapidly-growing tool that monitors
competition and trends within various medical device and therapeutic markets
requires a senior medical device analyst to its team. The Tracker is a
product that the investment community relies on for providing insight into
how different companies/manufacturers are performing each and every month
through the collection of data from thousands of clinical sites. To succeed
in this position candidates must possess the ability to meet strict
deadlines, interact with clients on a daily basis over the phone and
in-person and work in a team-orientated environment. As the Tracker
continues to grow, this candidate would also be responsible for managing new
analysts and data sets.
Qualifications
. Deep understanding of the medical devices industry and the
associated public companies
. Primary and secondary marketing research experience, specifically
internet based surveying
. Experience in patient-based spreadsheet modeling
. Some knowledge of fundamental equity research and what drives
company stock price movement
. Demonstrated ability to communicate effectively and persuasively,
both verbally and textually
. Superior organizational skills with meticulous attention to detail
. Ability to learn quickly
. Demonstrated ability to work in a team atmosphere
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Interested candidates should send a resume or CV to Eric Wong, wonge@.
The Pan Asian Cohort Study (PACS) is an NIH funded study to investigate diabetes and its risk factors within Asian American ethnic subgroups in a San Francisco Bay area cohort. (). The PACS capitalizes on existing patient electronic medical records in an ambulatory care setting.
The PACS is hiring a Data Quality Analyst starting immediately for Summer 2009 and Summer 2010 who will participate in developing the PAC database by refining data from the electronic health records. He or she will profile and refine the quality of demographic, clinical, laboratory, pharmacologic, and diabetes outcome data for the cohort population. The Data Quality Analyst will work closely with a Statistician and Information Analyst to ensure proper loading of quality data into the PAC database for the stated purposes of this research.
Responsibilities:
- Start: immediately. End: 09/01/09 (flexible)
- Explore existing clinical, patient-level data with the assistance of the Statistician and Information Analyst.
- Profile clinical data and investigate patterns and outliers in an effort to refine the consistency and quality of the data using SAS, JMP, and other analytic software with appropriate supervision.
- Partner with the Information Analyst and Statistician to efficiently build source and derived tables and data sets for the research team.
- Proposing and developing strategies and algorithms for cleansing data.
- Maintain security of patient-level data in a HIPPA compliant manner.
- Perform other tasks and responsibilities as needed.
Eligibility:
Required: Candidates must meet the following criteria.
- Bachelor's degree in Information Management, Informatics, Bioinformatics, Statistics, Computer Science, Mathematics or related field. Master’s degree or PhD desired.
- Post-secondary educator from an educational institution not already focused on research.
- Proficient with SQL, in particular Microsoft SQL Server.
- Experience with SAS and Enterprise Guide.
- Demonstrated experienced with managing large relational data sets. Consciousness in size and computing efficient with large data sets.
- Excellent analytic, research, and communication skills.
Desired: Strong candidates should also meet the following criteria.
- Proficient with SAS and Enterprise Guide.
- Experienced with clinical information.
- Experienced with JMP.
- Experienced working on a research team.
- Demonstrated responsibility of patient data in a HIPPA compliant manner.
Jobs that Crossed My Desk Through June 20, 2009
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Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
Email: rkhenais@
View my LinkedIn Profile
As we embark on another weekend, I wanted to send out a quick bulletin on some very hot positions our clients are currently interviewing for and seeking candidates through us. If you are interested in these opportunities, please send your resume to me at rkhenais@. Thank you! These are all in the SF Bay Area and we are unable to relocate candidates:
-Supplier Process/Quality Engineers (2-3 openings)
Qualifications include background in Six Sigma, SPC, supplier process improvments, knowledge in metals processing (stamping, laser welding, precision machining, etc.) and/or extrusion processes(especially multi-lumen catheters.
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-Validation Engineers (4 openings)
Must have background in medical device catheter processes
___________________________________________________________________
-Quality Engineer (1 opening)
R&D and medical device experience required. Other candidates have not worked out due to lack of R&D experience. Biotech/pharma in addition to medical device is a plus.
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Julie Julie@
A client has the following opening. Please note this is an entry level position -- so anyone who would be at the QA Manager level is overqualified and the client won't be interested.
Please let m e know if you know of anyone who would be a good fit.
QA Specialist: It is a contract (until the end of the year) to permanent position. It is local in the San Francisco Bay area and reports to the Director of QA. The company is well funded.
Duties include:
Ensuring proper reporting and handling of product incidents and customer complaints
Evaluating necessary corrective actions & assisting in developing system-wide action plans
Reviewing notifications of nonconforming material for customer submission
Requirements
Bachelor's with a minimum of 1 year of experience in drug manufacturing or in a FDA regulated facility (or equivalent) required. Previous experience should demonstrate expertise in cGMPs, FDA regulations, and an understanding of quality control principles
******************************************************************************************
Please Contact:Madan poovaiah
kpoovaiah@
(908)548-0764 X
Radiant Systems, Inc. is a Global IT Solutions provider, with
corporate offices located in NJ; we service clients in North America,
Europe and in Asia. To know more about Radiant Systems, Inc. please
visit us at
Job Details
Job ID:42232
Job Title:Qc Analyst I
Job Description:Duties: Daily duties and responsibilities would
include sample receipt, running LAL gel clot, reagent prep, lab
cleanup. Prior experience in any of the listed duties would be a plus.
The person must be able to work with minimal supervision.
Job Skills:.
Estimated Start Date:
Location:Vacaville, CA , USA
Duration:5 Months
Special Notes:Regards, Madan Poovaiah Radiant Systems Inc. 107 B,
Corporate Blvd, South Plainfiled, NJ - 07080 E-Mail:
kpoovaiah@ Phone: 908 315 1175 URL:
****************************************************************************************
Two regulatory positions sent to me by HR manager at Intuitive Surgical, Sunnyvale
Director of Regulatory Submissions
Please apply to our website
Primary Function of Position:
Develop, manage and implement regulatory strategy to maintain existing product lines or support entry into new markets upon creation of new products. Manage submissions, insure timely regulatory filings and complete communications and documentation processes including technical files. Lead, manage and maintain regulatory clearances, documentation and approvals with necessary filings and communications to appropriate parties. Oversee and manage communications with government / regulatory agencies on a global basis. Grow, develop and manage team to interface and support all regulatory requirements of the company with the appropriate external organizations. Manage overall required internal quality document system.
Roles and Responsibilities:
This position has responsibility and authority for:
• Play a key role in the development of the company’s regulatory strategy for both domestic and international clearances.
• Review and approve all submissions for 510(k)s, IDEs, to FDA, technical files for EU, Shonin application for Japan, and registrations for rest of world to obtain regulatory clearances and approvals for new products and product changes in a timely manner.
• Establish, review and approve “Memo to File” reports to support internal filings for product development projects and product changes.
• Provide oversight and assistance to product development teams for completion of Technical Files (CE Mark) for Europe, Shonin for Japan and Registrations for rest of the world (ROW).
• Support product development teams on regulatory issues, including review of documentation.
• Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance).
• Oversee management of internal quality document system processes and maintenance.
• Continuous improvement and management of the submission process in accordance with Intuitive Surgical Product Development Process.
• Drive International regulatory filings and approvals.
• Work directly with regulatory agencies on regulatory issues and submissions.
• Maintain regulatory clearances and approvals with necessary filings and communications.
• Provide leadership and direction to Regulatory team.
Required Skills:
Competency Requirements: (Competency is based on: education, training, skills and experience.)
In order to adequately perform the responsibilities of this position the individual must have:
• Minimum 8 years relevant regulatory experience with 5+ years of experience in submissions and technical documentation for a medical device company.
• Experience in creating 510k, IDE, memo-to-files, and technical files for new products.
• Experience in new product introduction.
• Experience in verification and validation methods and documentation.
• Experience with third-party testing such as UL / IEC product testing, biocompatibility testing, sterilization.
• Minimum of 8 years experience leading teams with a solid track record in hiring and developing team members.
• Excellent ability to work in cross-functional environments.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.
• Good interpersonal skills and able to work well with cross-functional teams.
• Good project management skills.
• Experience working directly with the FDA, Notified Bodies and other governmental agencies on Regulatory matters on a global basis.
B.S. or higher in sciences. Biomedical Engineering, Electrical Engineering or Mechanical Engineering a plus. Masters’ degree preferred.
__________________________________________________________________
Senior Regulatory Analyst -Intuitive Surgical
Primary Function of Position:
Provide leadership to development, new product introduction, and manufacturing teams for assessing the impact of design inputs and outputs on regulatory filings and compliance. Create awareness within the organization regarding the international and domestic regulation and the product specific standards. Additional responsibilities include maintaining regulatory filings and licenses, and interacting with regulatory agencies during inspections.
Roles and Responsibilities:
• Prepare and submit 510Ks (FDA) to obtain regulatory clearances and approvals for new products and product changes in a timely manner
• Prepare “Memo to File” reports to support internal filings for product development projects and product changes
• Provide oversight and assistance to product development teams for completion of Technical Files for Europe (CE Mark)
• Prepare and submit notifications to European and other international regulatory agencies for new products and changes to existing products
• Support product development teams on regulatory issues, including review of documentation
• Provide leadership on documentation issues and mentor teams on requirements
• Maintain regulatory clearances and approvals with necessary filings and communications
• Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
• Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process
• Work directly with regulatory agencies on regulatory issues and submissions
Perform other duties as required
• Required Skills
• Education
o B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
o Non-technical degree with equivalent complex medical device experience acceptable
o RAC (regulatory affairs certified) desirable
• Experience
o 8 years relevant experience working in a medical device company
o 6 years of experience in submissions and technical documentation for a medical device company
o Experience with new product development projects for complex product
• Skills
o Ability to create 510k, memo-to-files, and technical documentation from scratch for complex new products
o Experience in verification and validation methods and documentation
o Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
o Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
o Good interpersonal skills and able to work well with cross-functional teams
o Good project management skill
• Training at Intuitive (on the job):
o Agile: Be able to create, review, and approve ECOs. Facile in using Agile search capability to research change history on documents, parts and assemblies
o SAP / Datasweep: Understand how database is used for quality records and be able to query database and retrieve basic information for review of Device History Records for first human use on new product releases
• Special Training needs (may be from experience)
o Expertise in U.S. FDA Pre-Market notification [510(k)] process and guidelines
o Expertise in the European Medical Device Directive
o Expertise in Canadian Medical Device applications
****************************************************************
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 that has received a lot of attention. The following are some new job postings:
--- Director in Toxicology (San Francisco)
--- Database Developer (NJ)
--- Sales Manager (TX)
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!
***************************************************************************************
Debbie Winkelbauer dwink@
Apple&Associates
Recruiting Specialists in Pharmaceutical, Medical Device & Biotech
Industries
800-326-8573
Production Superintendent St. Louis, MO
Manage multiple Manufacturing Supervisors and/or Process/Quality
Engineers representing varied shifts and groups of employees in a
pharmaceutical manufacturing environment producing sterile
pharmaceuticals.
Maintain cGMP operational compliance with US and international
Regulatory Agencies (OSHA, FDA, NRC, EU, BDB, DHSS, etc as
applicable).
Develop and maintain department budget including COP, scrap, yield, Op
Ex Cost Savings, and headcount requirements.
Lead direct and indirect reports which include both exempt and
non-exempt employees.
Assists in the development and transfer of new products to the facility.
Establish standardized Manufacturing schedules to meet customer demands.
Ensure equipment remains in a validated state and is current with
calibration and PM schedules.
Embrace and drive the plant culture of Continuous Improvement and
Total Productive Maintenance.
Manage the cGMP Production Operations.
Supervise departmental personnel directly and through subordinate
managers and/or supervisors.
Ensures the maintenance of their department, premises and equipment.
Ensures the appropriate validations are completed on time.
Ensure training of department personnel is completed on time.
Ensure manufacturing documents are properly reviewed and approved
prior to release to the Quality Unit.
Requirements:
Bachelor’s degree preferably in Pharmaceutical Science, Chemistry,
Biology, Microbiology or Engineering.
Seven years experience in human or animal pharmaceutical manufacturing
with a minimum of three years of leadership experience.
Experience with radiation safety programs preferred.
Knowledge of aseptic techniques.
Knowledge of business finance.
Highly organized and capable of operating in a varied, fast-paced environment.
**************************************************************************
Dean Tracy
careers@
An independent recruiter. I have a client located in Miplitas and
looking for a QA Supplier Engineer in the medical device industry, pay
rate $110K, direct hire position.
Can you pass this lead out to candidates that meet the qualifications?
Thanks in advance.
*************************************************************************************************
Madan Poovaiah Radiant Systems Inc. 107 B,
Corporate Blvd, South Plainfiled, NJ - 07080 E-Mail:
kpoovaiah@ Phone: 908 315 1175 URL:
Please Contact:Madan poovaiah
kpoovaiah@
(908)548-0764 X
Radiant Systems, Inc. requests you to review the following contract
opportunity. If you are willing to consider this opportunity, please
submit your resume by clicking on the Reply button on your Email
Client. Feel free to contact us for any additional information.
Radiant Systems, Inc. is a Global IT Solutions provider, with
corporate offices located in NJ; we service clients in North America,
Europe and in Asia. To know more about Radiant Systems, Inc. please
visit us at
Job Details
Job ID:42108
Job Title:Qc Analyst II
Job Description:Duties: The successful candidate will perform a
variety of standard laboratory activities in support of testing raw
material, in-process intermediate, bulk, stability, and final vial
samples. The successful candidate will be trained to perform reagent
preparation/review, equipment maintenance activities (cleaning and
calibrations) and general laboratory maintenance activities
(stocking/disposing of chemicals, and maintaining effective work place
organization (5S). The candidate will also be responsible for sample
aliquotting and sample management/disposal. These activities will be
performed in a current Good Manufacturing Practices environment.
Skills: The schedule is dayshift which may include weekends and
holidays. A BS/BA degree in Biochemistry, Microbiology, Chemistry, or
related scientific field or equivalent combination of education and
work experience required. 0-2 years’ relevant laboratory experience.
Familiarity with laboratory equipment, analytical methods and aseptic
technique are preferred. The successful candidate will have a high
attention to detail and the ability to follow written procedures. The
individual must be able to work independently as well as within a
group. Computer literacy and experience working in a GMP environment
are preferred but not required. The position is located at the
Vacaville Facility. Education: A BS/BA degree in Biochemistry,
Microbiology, Chemistry, or related scientific field or equivalent
combination of education and work experience required.
Job Skills:A BS/BA degree in Biochemistry, Microbiology, Chemistry, or
related scientific field or equivalent combination of education and
work experience required.
Estimated Start Date:7/6/2009
Location:Vacaville, CA , USA
Duration:12 Months
*****************************************************************************************
Marketing Coordinator (Diagnostics Company)
Reply to:
Date: 2009-06-04, 2:09PM
About XDx
XDx is a molecular diagnostics company based in Brisbane, California, funded by Kleiner Perkins and other top tier venture capitalists. Setting the stage for a new era in personalized medicine, XDx is one of the first companies to develop and commercialize practical applications built on insights from the Human Genome Project. The company has developed a proprietary new method for noninvasively monitoring the immune system by measuring gene expression in a patient’s peripheral blood. The technology offers the potential to decrease healthcare costs and significantly improve the quality of life for patients with a variety of life-threatening or life-altering, immune-mediated diseases.
Our culture is based on a belief in pioneering and innovation, integrity, people development, community, and balance in our day to day lives. The company offers excellent benefits. This is a place where you can make a difference, learn new skills, and work with outstanding people.
Job Profile
The self-starting marketing coordinator will manage the coordination of meetings, tradeshows, and sales and marketing collateral, and other duties as assigned, to help drive growth of XDx’s product(s). In this position, the primary focus will be to set up meetings, coordinate logistics, interface with vendors and other meeting planners, and to communicate effectively. The Marketing Coordinator will coordinate projects and manage all Sales and Marketing collateral, both in print and electronic forms. The Marketing Coordinator will serve as a liaison between the commercial group, regulatory review, and creative partners. The Marketing Coordinator will use exceptional written and oral communications skills to communicate to customers and internal audiences. This position will interface with all of XDx’s departments, but especially Sales and Medical Affairs, as well as professional societies, customers, and outside vendors. Additional responsibilities will include tracking marketing expenses, surveying online capabilities and needs, and supporting all tactical initiatives.
Responsibilities
• Coordinate meetings, tradeshows, related customer events, or meeting activities as required
• Maintain timelines and deadlines; manage relationships with meeting personnel; manage other resources and ensure related projects are completed on schedule; attend meetings, tradeshows, and customer events as needed
• Ensure that relevant contracts, purchase orders, and invoices are processed correctly and in a timely fashion, and maintain orderly records of all contracts, purchase orders and invoices
• Ensure that booths needed for tradeshows arrive intact and on time; coordinate shipping as needed and periodically inspects tradeshow booths
• Manage relationship with fulfillment house and printers; order article reprints as they become available; check shipping and printing jobs for quality
• Create and maintain tracking and reporting tools
• Oversee the management of giveaways; assist with selection and distribution of giveaways for meetings, tradeshows, and company events
Qualifications
• BA/BS or equivalent in related field with 2-4 years of experience
• Must be self-directed
• Proficient in MS Office with particular emphasis in Excel and PowerPoint
• Exemplary internal and external customer service skills
• Excellent communication skills: written and verbal
• Strong ability to work in a team and in an individual environment
• Ability to work on multiple projects and to prioritize tasks
• Proficient in standard personal computer applications
To Apply
Please email your statement of interest and resume to jobs@. Please specify which position you are applying for by including the Job Code (MA- 07127-CL) in the subject line of your email. If possible, submit resume as a Word document. Principals only please.
XDx is an Equal Opportunity Employer.
• Principals only. Recruiters, please don't contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.
Original URL:
________________________________________________________________________________
Janet Jarboe
Jarboe & Associates
Serving Professionals Since 1997
1748 Clear Creek Court
Windsor, CO 80550
janetjarboe@
970-686-5899 (office)
970-689-2962 (cell)
janetjarboe@
Director, Regulatory Affairs - California (reports to Vice-President)
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.
__________________________________________________________
Formulation Scientist-California
o The design and execution of experimental programs to develop phase I and
II clinical formulations
o Supervise and execute pre-formulation activities, such as (pH-dependent)
solubility, stability and excipient compatibility testing of new products
o Develop parenteral IV formulations of adequate stability for research,
pharmacology, toxicology and early clinical studies
o Characterize prototype formulations and support development of
corresponding analytical methods
o Formulation process development and scale-up activities including DoE.
o Maintain a current awareness of formulation and delivery technologies.
o Maintain a current awareness of and enforce applicable government
regulatory, safety, occupational health, and environmental requirements.
o 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
o Contribute to CMC sections for regulatory filings.
Requirements: PhD in Pharmaceutics, Chemical Engineering, or a related
field with 1-3 years of industrial experience required.
- 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 advantageous
- 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.
- Ability to work effectively and comfortably in a multi-disciplinary team
under defined timelines
- Excellent leadership, teamwork and organizational skills
- Solid verbal and written communication skills
-Application of biopharmaceutics principles and clinical PK data towards
formulation development and optimization
_________________________________________________________
Purification Development Associate/Scientist--California
Will be assigned responsibilities for the development and purification of
monoclonal antibodies at bench and pilot scale, perform work to support GMP
protein purifications, as well as help to support the equipment and
documentation requirements of a GMP manufacturing suite and development
laboratory. Essential functions include, but are not limited to the
following:
• Establishment and operation of small-scale purification processes to
support research and process development.
• Support of upstream and downstream activities such as purification
development and downstream recovery development.
• Independent design, execution and interpretation of experiments related to
the development of purification processes.
• Small to mid-size purification processes using liquid chromatography
operations.
• Bioassays, biochemical assays, and HPLC based assays.
• Writing GMP documents, maintaining a scientific notebook, performing
validation activities, and presenting written and oral reports.
The qualified candidate will have developed a purification process for early
clinical trials of a therapeutic monoclonal antibody. The position requires
a science degree in Biochemistry, Biochemical Engineering or related
discipline in addition to production or research experience in the
development and scale-up of purification processes. The education
requirement may be combined with work experience as follows: PhD and 5+
years relevant experience. Specific knowledge of antibody purification
processes is required. Excellent communication and documentation skills are
required. Working knowledge in the areas of GMP parenteral manufacturing,
purification, expertise in analytical and/or preparative liquid column
chromatography systems.
______________________________________________________________
Manager, Clinical Pharmacology-Illinois
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
management. Attends professional meeting and presents study results as
appropriate. Publishes study results as appropriate.
10. SOPs and Regulations. Understands 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.
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
_________________________________________________________________
Pharmacokineticist, Clinical Pharmacology-Illinois
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.
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.
**********************************************************************
Ruba Khenaisser
Senior Engineering Recruiter
Aerotek Inc.,
395 Oyster Point Blvd. Ste. 119
South San Francisco, CA 94080
rkhenais@
Regulatory Affairs Manager (Redwood City)
6-10 years experience, pays $85-110K
Must have experience in PMA medical devices, protocol writing, revision and review
If this doesn't fit your profile, free to forward this information to anyone you know who can benefit. Interested applicants please send resume to rkhenais@. Thank you!
************************************************************************************
Patrick T. Heiden
Executive Search Consultant
Direct: (919) 323.8721
Cell: (919) 609.1729
pheiden@
Cambridge RTP San Francisco
You must be on-site, so if you know of anyone in the NJ area that might be interested, please forward and have them contact Patrick.
Title: Sr. Consultant, Global Promotions
Location: NJ
Rate: $140.00-$160.00 per hour / 40 hours per week (Flex schedule available)
Length: 6 Months
MAJOR ACTIVITIES AND RESPONSIBILITIES:
50% Reviews and approves promotional materials. This includes but is not limited to initial review and approval of said materials, QC samples, and coordination of FDA submissions in a timely manner and in accordance with FDA regulations. Reviews may also include other materials pertaining to Company products or programs that may or not be included (i.e., press releases, external presentations) and may include global promotional materials.
30% Participates at weekly PMT meetings, including concept meetings
20% Other activities include:
• Activities conducted by Associate Manager and Manager, Global Promotions
• Familiar with developments and unmet medical needs of therapeutic area; serves as resource to internal and external parties.
*************************************************************************************************
Interested candidates please connect with me via email at shannonp@.
Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
Web:
Medical Writers, Medical Communications
New York, NY, and Central NJ
New opening today NYC medical writer- full time, on-site for a medical communications agency. PhD, PharmD, MD degree required and experience writing for oncology or rheumatoid arthritis. Openings also in central NJ.
************************************************************************
Interested candidates please connect with me via email at shannonp@.
Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
Web:
Associate Medical Director, Medical Communications
San Francisco, CA
Full-time position, on-site, with a medical communications agency. Requirements include: PharmD, PhD, MD degree. Oncology, asthma, and/or ophthalmology experience a plus.
***********************************************************
Jessica Leveille
Orbis Clinical
Manager of Biomedical Delivery Services
200 Unicorn Park
Woburn, MA 01801
Ph 781-569-0607 x1915
Fax 781-569-0608
JLeveille@
Senior Medical Writing Consultant
Northern MA
Initially, a 12-month contract-to-permanent role, if consultant is interested.
Responsibilities
Responsible for coordination of medical writing processes, development and review of clinical study protocols, synopsis, study procedure manuals, independent review charters and clinical study reports, etc. Acts as medical writing liaison to work with medical directors, clinical operations, biostatistics and data management and clinical QA and compliance, Manages review process of all clinical documents, coordinates round table discussions if necessary. Helps biostatistics and regulatory affairs groups in regulatory submissions. Provides assistance in preparation of abstracts, manuscripts and other presentations for scientific and sales meetings.
Qualifications
Master's degree in clinical or life sciences or related field, approximately 5-8 years experience in medical writing in clinical development of drug, device, or imaging products. Experience in cardiovascular or imaging field is preferred. Experience in preparation of NDA submission documents preferred. Experience in establishing medical writing process and guidelines desired.
***********************************************************************************
Jobs That Crossed My Desk Week of June 13, 2009
***********************************************************************************
Darshana Varia Nadkarni, Ph.D.
wd_darshana@
Cell: 408-898-0000
Can you possibly find someone who might fit the description below? They are specifically looking for a non-PhD bench science research associate with ELISA, HPLC, cell biology, immunoassays experience in the industry (not just academia). I told them that I will get them the right person who matches what they are looking for by monday. see description below. I will appreciate any help. Thanks so much.
Research Associate: Cell Biology, Chemistry, Biochemistry, Physiology or related areas (B. S. / M. S.)
A dynamic company in the Bay Area, involved in the development of tissue-engineered and drug-delivery solutions for chronic diseases, is looking for a Biologist. The applicant must have a minimum of 10 years experience working in a laboratory and must be proficient in the development, standardization and routine running of quantitative assays for small molecules, peptides and proteins using a variety of techniques such as FTIR, HPLC, and immunoassays. The applicant will work with a multidisciplinary team of experts and provide assay support with minimal supervision on various ongoing projects. The applicant will also support and work in the tissue engineering lab. This will require proficiency in cell culture experiments and experience with cell biology and/or protein chemistry. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Additionally, the applicant will also have broad research experience to be able to provide support in a variety of routine biological and chemical laboratory procedures as needed. Salary and benefits are commensurate with experience.
************************************************************************************
Contact 24 and Me for open positions in Mountain View at
Genetics just got personal.
Combining web development, computer science, genetics, and informatics, we are at the forefront of a new era in personal genetics. Join a talented, ambitious team that is creating truly novel technologies and products that will change the way people see themselves and the world.
All positions are based in our main office in Mountain View, CA.
If you cannot find a specific position below that fits your skill set, please fill out a general application.
Join one of our teams:
[pic]Engineering
• Software Engineer
• Software Engineer in Test
• UI Engineer
• Software Engineer
• Software Engineer in Test
• UI Engineer
[pic]Marketing
Director, Marketing
• Director, Marketing
[pic]Product
• Product Manager
• UI Designer
• Product Manager
• UI Designer
[pic]Science
• Scientist, Content Curation
• Software Engineer, Science
• Statistical Geneticist
• Scientist, Content Curation
• Software Engineer, Science
• Statistical Geneticist
[pic]Writing
• Product Writer
• Science Writer
*************************************************************************************
If you, or someone you know,is intereseted and qualified please contact Lee directly at;
Lee Gellins
FPC Hilton Head
843-842-7221
Lee@
A critical piece is the Medical Director for Periodontal. This candidate must have industry experience but not necessarily as a Medical Director. I am listing the priorities below. The company does not want someone from the commercial side.
Need to have (in this order):
1. Specialty clinical training (Perio or oral or oral maxillofacial and maybe ENT) - MANDATORY
2. Industry experience
3. Science training (preferably cell biology, developmental biology, molecular biology, regenerative medicine, tissue engineering).
1 & 2 - MANDATORY
Industry is a little more important than science for the MD role. Science is icing on the cake.
**********************************************************************************************
Joy Bridges
Executive Recruiter
[pic]
LEGACY MEDSearch
Emerging Medical Technology Recruitment
Phone: 407-898-4440 ext. 104
Fax: 407-898-4494
Joy@
*Our current Medical Device Jobs
Urgent need job……..They will hire on the spot for right person in Bay area
Senior R&D Engineer - Orthopedic Surgical Devices
The Research & 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.
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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
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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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Harris Recruiting LLC
Tammy Harris / Placement Director
Office: 205-421-1772
Fax: 205-629-3068
Cell: 205-616-7946
harrisrecruiting@
See 5 positions below:
POSITION #1 Director, Regulatory Affairs
Responsibilities:
With the management team, determine proper strategy of communication with FDA in regard to written, telephone, and in person meetings to achieve business and regulatory objectives.
-Learn, understand, and interpret clinical and device technology in order to assure proper strategy and implementation.
-Write IDE submissions, including original IDE and supplements. Responsibility includes overall submission responsibility as well as individual items within the submission. Learn and understand sources of data within the company.
-Create, update, or approve labeling. Oversee external translation process.
-Create technical files, including clinical section, for CE Mark application; interface with Notified Body to achieve CE Mark.
-Create documentation necessary to support European and OUS clinical trials.
-Submit required clinical trial and IDE reports to FDA, IRB, Ethics Committee, and other agencies.
-Advise and influence supporting processes, including design control, risk management, clinical, compliance and quality system.
-Determine requirements and advise strategies to meet state radiation laws.
Qualifications:
- Must have demonstrated understanding of complex clinical applications, preferably ophthalmic, utilizing software controlled class II or III devices. Experience with radiation therapy is desirable. Have experience with FDA software guidance in prior regulatory submissions
-Prior success in preparing IDE submissions in a relevant technology and communicating/negotiating with FDA on those submissions (minimum 5 years)
-Prior experience in 510(k) or PMA preparation of electro-mechanical, software controlled devices, including reporting of clinical study progress
-Prior success in submission of technical files for class IIa, IIb, or class III devices for CE Mark
-Minimum 15 years of relevant medical device experience, including 5 years at Manager or Director level
-Minimum BS degree; Master's preferred
-Must be an excellent writer, able to determine and organize proper message to meet communication goals.
-Must be a team player, able and willing to work closely with R&D organization
-Must operate independently to achieve goals, exhibiting good decision making
-Must be capable at creating and working with complex Word and Adobe documents (or other alternative programs) for complex submissions
-Biocompatibility and sterilization experience desirable.
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POSITION #2 VP, Ops/Plant Manager
Location
San Jose
Role Statement
Responsible for the management and direction of the Operations group in ensuring product is manufactured, and delivered in accordance with quality and GMP standards. Is a proactive leader and an effective team player in launching products, recognizing that innovation is the Company's number one strategy.
Key Responsibilities
• Holds management with executive responsibility for plant operations. Scope includes Quality System compliance, product quality, customer service, and business metrics
• Ensure means and controls are in place to produce product in accordance with GMPs, the Quality System and defined product and process specifications; including but not inclusive of process controls, process validations, preventative maintenance, equipment calibration, personnel training, supplier and distribution controls, among other related responsibilities
• Member of New Product Investment Boards which oversee new product development and introduction. Responsible for the oversight of manufacturing process and equipment development as well as new product market delivery
• Direct and manage Operations resources; areas include Production, Purchasing, Planning, Logistics, Manufacturing & Equipment Engineering, Process Development Engineering, Industrial Engineering and Packaging Engineering
• Evaluate and assess the developmental/skill needs of staff on a continuous basis to ensure appropriate competencies exist to meet project assignments. Ensures that technical staff are assigned to appropriate work tasks
• Maintains an effective workforce, optimizing work loads and staffing levels; organize, motivates, disciplines, and trains employees; anticipates and reacts swiftly and effectively to performance issues
• Develops and implements metrics used to drive the business
• Develops and set operational continuous improvement goals (guided by Lean and Six Sigma tools)
• Provides direction to meet customer expectations for product quality and availability as well as developing means with which to measure performance and manage goals
• Oversees materials management using MRP II system
• Ensures that inventory levels satisfy the Marketing Demand Forecast
• Oversees management of value improvement engineering function to achieve cost/productivity/yield, quality and cycle time reduction goal
• Oversees spending of expense items and capital equipment, investing prudently in capital equipment to increase productivity
• Prepares annual budget and monitors spending
• Prepares regular activity reports
Quality Systems Duties and Responsibilities
Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area supported. Ensure employees are trained to do their work and their training is documented.
Qualifications
Minimum education:
Bachelor's Degree or Masters Degree in Engineering, Finance or equivalent experience
Minimum experience :
12+ years experience in manufacturing, including 2+ years "hands on" experience in production, materials, or line support engineering, and 3+ years senior operations management experience in a low volume, high value-added business using World Class methods. Must be proactive, a strong team player, and an open and honest communicator. Must be committed to an environment of continuous improvement and to the management systems and techniques that harness the organization toward that goal. Or equivalent combination of education/experience required to perform at this level.
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POSITION #3 Quality Manager II.
Manages a team of about 20, 1 is a manager, and there is a Pr. Level manages the Complaint team. Direct reports is 7. Includes Complaints, CAPA, Auditing, Quality Systems, Manufacturing Quality.
General Summary:
The Quality Compliance Manager is responsible for the administration, supervision, and development of the Electrophysiology Quality Compliance Department.
Specific Duties and Responsibilities:
-Establish and support a work environment of continuous improvement that supports the company's Quality Policy, Quality System and the appropriate regulations for the area supported. Ensure employees are trained to do their work and their training is documented.
- Provides significant guidance and approval regarding quality system strategies and approaches.
-Develops guidance and training to staff, assists subordinates in attaining career goals, motivate individuals to achieve results, and recruits and maintains a high quality staff.
- Determines appropriate staff levels, schedules and resources to contribute to overall organizational success.
-Policy/procedure writing to ensure local regulatory compliance according to all applicable quality and regulatory standards, regulations, and the company's corporate policies.
- Manages the following functions: CAPA, Complaint/MDR Processing/reporting, Internal Auditing, Quality Systems Review Board, for each of these areas, develop and maintain periodical trending reports. Provides overall trending data and participates/conducts Management Review. Acts as liaison and contact to external auditing agencies
- Ensure the General Training requirement of Introduction to Quality System is delivered to for new employees as part of the New Hire Orientation.
-Drive quality projects by evaluation and implementation of new processes and technologies relating to improving quality system management
-Work cross-functionally and cross-divisionally in identifying and resolving technical issues.
-Develops and monitors department budget.
Position Qualifications:
10 – 14 Years experience in medical device quality with BS or equivalent and 5 years of supervisory experience; or equivalent combination of education and experience to perform at this level.
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POSITION #4 Pr. Regulatory Affairs Specialist
General Summary:
The Principal Regulatory Affairs Specialist will prepare a full range of regulatory strategies and the corresponding documents for submission, review and approval by FDA.
SPECIFIC DUTIES AND RESPONSIBILITIES:
• Fully support the Quality Policy by building quality into all aspects of my work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for my position and documenting that training).
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
• Filings include PMA, 510k, IDE, and letter-to-file.
• Schedules, plans and conducts meetings with Office of Device Evaluation.
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
• Plans and coordinates implementation of validation strategies and schedules with Engineering, Clinical Research and Quality Assurance personnel, for multiple project teams.
• Develops and implements departmental and divisional policies and procedures.
• Supports the creation of written company standards and policies to support ISO 9000, including the creation of technical files, design dossiers and CE Marking.
• Reviews and approves document change orders.
• Assists with regulatory inspections by FDA investigators or Notified Body auditors.
• Shares responsibility and authority for maintaining GMP and ISO compliance throughout the organization.
• Develops and implements regulatory strategies for new and modified products.
• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Supports highly technical or major business segment product lines, special projects or strategic initiatives.
• Other duties as assigned.
Position Qualifications
• Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline. Professional certification(s) preferred. 8 plus years Regulatory Affairs medical industry experience, preferably with cardiovascular disposable devices.
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POSITION #5 Senior Clinical Research Associate
Status: Full Time
Location: Fremont, CA
Company Description: Located in the Bay Area this dynamic new VC funded start-up company is dedicated to developing breakthrough innovative products for the management and treatment of diabetes. The company offers a competitive compensation package that includes stock options, excellent medical benefits, and a supportive work environment.
Responsibilities:
-Plan and execute clinical trials for a continuous glucose monitoring device.
-Facilitate new site contracts, clinical trial agreements, and budget. Interact with Principal Investigators.
-Create study documentation, including clinical protocol, case report forms, and informed consent. Interact with IRB.
- Qualify, initiate sites, train site personnel, execute studies and close out.
-Manage device inventory, study supplies, shipping, study logistics.
-Develop and implement clinical SOPs
-Coordinate activities of research associates in execution of clinical studies
Requirements:
-3-10 years experience as a clinical research associate for a medical device
- BS or MS degree in a technical or medical field, RN a plus.
- Working and detailed knowledge of cGCPs
-Experience with continuous glucose monitoring a plus.
- Organized, thorough, and detail oriented
- Energetic self-starter, with good communication and documentation skills
- Ability to work well in a small dynamic start-up team
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I received these specific jobs from PackagingJobsonline at
1-800-701-6809
They also list a Job Seeker Center at
I’ve never posted their jobs before.—see what you think and let me know.
Their home page claims “Packaging Jobs Online is the packaging field's ultimate job board, building up the field's largest inventory of packaging-related jobs, with new jobs being added daily.
|Job: PACKAGING - PROCESS - PLANT ENGINEER |
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|communications within... |
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|Employer: Lid Works |
|Description: Manage maintenance operation in accordance with plant policies and procedures.Ensure smooth operation of machinery. Supervise |
|maintenance department... |
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|Category: Personal care |
|Function: Procurement/Sourcing |
|Employer: Energizer Personal Care - Playtex Products |
|Description: Responsible for the Global procurement/purchasing responsibilities of Playtex required raw materials for both internal and external |
|manufacturing.... |
|Job: President |
|Location: , CA |
|Category: Package materials supplier |
|Function: Package Development Eng. |
|Employer: Lithotype |
|Description: We are a leader in flexible packing and printing industry located in the San Francisco Bay Area is seeking a President to provide |
|strategic leadership... |
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|Employer: Atlas Box & Crating Company |
|Description: Responsible for packaging development from initial concept through material specification, design, documentation, prototyping, test |
|validation,... |
|Job: Sales Associate |
|Location: Orange County, CA |
|Category: Package machinery supplier |
|Function: Sales/Marketing/Biz Dev. |
|Employer: Integrated Equipment Solutions Company |
|Description: Full sales and service packaging equipment solutions integration company, offering a comprehensive line of pharma grade quality mid |
|level priced... |
|Job: Packaging Account Executive |
|Location: Hauppauge, NY |
|Category: Package materials supplier |
|Function: Package Development Eng. |
|Employer: Spotless Enterprises Inc. |
|Description: We are a global services organization consisting of two distinct businesses - Retailer Services and Facility Services. Operating |
|under the brand... |
|Job: Category Packaging Engineer |
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|Function: Packaging Machinery Eng. |
|Employer: Unilever |
|Description: Our mission is to add Vitality to Life. We meet everyday needs for nutrition, hygiene and personal care with brands that help people |
|feel good, look... |
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Other Information for Those in Transition
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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
Here’s also website dedicated to life science recruiting with listings in various sectors of our industry. Go to and see if this site is helpful.
BeakerBeat, has a weekly video webcast of everything life sciences; and claims 11,000 open positions and 200 video-enabled company profiles on their site.
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
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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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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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