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    Duties

    Summary

    Serves as one of three to four analytical chemists in the Biopharmaceutical Laboratory Section (BPLS), all sharing in the scope of work in the laboratory. Analytical chemists are assigned to MCTs to provide analytical results (potency, strength, biopharmaceutical dissolution, and chemical degradation/expiration dating) for the drug dosage forms used in these assigned MCTs.

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    Responsibilities

    Serves as a chemist for the BPLS of the Division of Quality Assurance. The incumbent is responsible for assuming a chemist's role for a selected number of assigned multicenter clinical trials (four or more), acts as the chemist for those assigned clinical trials, and is responsible for the planning, execution, and reporting of the analyses for those assigned clinical trials.
    Independently develops, modifies or adapts and validates all analytical test methods used for the analyses of active pharmaceutical ingredients (API), finished dosage forms, excipients and blended mixtures of pharmaceutical products to manufacture clinical supplies for assigned clinical trials.
    As the chemist for the assigned clinical trials, the chemist will assist other chemists in the correct use of new analytical methods and/or techniques he/she developed as well as analytical instrumentation. If specialized equipment is required for testing and analysis, will procure, install, adapt, and validate such analytical equipment. Chemist will assist other chemists in the correct and timely performance of this analytical testing.
    Serves as a member on the matrix management team for assigned multicenter clinical trials. On a daily basis, perform, organize and schedule the analytical testing in the laboratory ensuring deadlines are met.
    Assures appropriate, consistent, and accurate communication between all laboratory personnel and with personnel in other organizational sections (Matrix Management) of the Center.
    Independently develops accurate and comprehensive laboratory budgets for all assigned CSP and non-CSP studies during the planning phase.
    Develops and monitors the workload measurement systems for the laboratory, so that all activities are appropriately and accurately documented for assigned clinical trials. And other duties as assigned by the supervisor.

    Work Schedule: Monday-Friday, 8:00am-4:30pm
    Compressed/Flexible: Not Available
    Telework: Not Available
    Virtual: This is not a virtual position.
    Position Description/PD#: Chemist/PD02938-A#02938A
    Relocation/Recruitment Incentives: Not Authorized
    Financial Disclosure Report: Not required

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    None

  • Job family (Series)

    1320 Chemistry

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/556776500. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.