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San Francisco Bay Area, CA

  • Analytical Chemist

    Pleasanton, CA

    SUMMARY:

    The key responsibilities of this role are to:
    – Maintain the analytical chemistry laboratory;
    – Support development and manufacturing by performing sample analysis; and
    – Contribute to regulatory approval by validating the equipment and processes.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:
    1. Perform analytical and other wet-chemistry related test methods.
    2. Generate standards and formulations per procedures.
    3. Conduct analysis of incoming materials, in-process, and finished product per procedures.
    4. Perform QC testing to support the development, manufacture, and release of products.
    5. Deliver timely, accurate and reliable results following good laboratory principles and
    established SOPs.
    6. Compile data for documentation and prepare reports. Review analytical results.
    7. Maintain HPLC, light-obscuration particle detector, and other laboratory equipment; including
    support of preventative maintenance, implementing performance qualification, and other
    requirements.
    8. Conduct root cause analysis and OOT/OOS laboratory investigations when necessary.
    9. Apply knowledge of Good Manufacturing Practices and Good laboratory Practices on a daily
    basis.
    10. Other duties as assigned.

    QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
    • Bachelor of Science with a minimum of 8 years of experience in the medical device industry.
    • Proven track record in an analytical role. Must be an expert in HPLC and other laboratory
    equipment. Experience with paclitaxel is a plus.
    • Demonstrated ability to work within a Quality System and follow all established procedures.
    • Strong knowledge of standards and regulatory requirements.


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