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    Duties

    Summary

    This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) located in Silver Spring, MD.

    This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-18-DE-10156706 under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both.

    Additional selections may be made within the same geographical area FDA-wide.

    Learn more about this agency

    Responsibilities

    The incumbent of this position will:

    • Serve as Branch Chief by providing overall directions to the branch staff for regulatory review of Investigational New Drug applications (IND), Biologic License Application (BLA), Investigational Device Exemption (IDE), Pre-Market Notification [510 (k)], Pre-Market Approval (PMA) applications, and their supplements/amendments associated with the development, manufacture, and clinical use of cellular and gene therapy products, tissue engineered products, xenotransplantation product, and certain medical devices.
    • Plan work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work.
    • Serve as the product authority for regulatory review on chemistry, manufacturing and controls (CMC) for cellular therapies, including tissue engineered products and xenotransplantation products, and related medical devices.
    • Decision-making for CMC regulatory documents pertinent to cellular therapies in conjunction with the Division Director.

    Travel Required

    Occasional travel - You may be expected to travel for this position.

    Supervisory status

    Yes

    Promotion Potential

    15

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/493412700. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.