• Help

    Duties

    Summary

    This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) located in Silver Spring, MD.

    This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-18-DE-10150833 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

    • Perform scientific regulatory review for Biologics License Applications (BLA) and supplements for biological products, Pre-Market Approval (PMA) applications and supplements for medical devices, New Drug Applicants (NDA) and supplements and Drug Master Files associated with BLAs and PMAs as a member or of chairperson of the review committees for these submissions.
    • Evaluate facility design, operation, manufacturing and testing procedures and compliance with Good Manufacturing Practices (GMPs)in these submissions and pre-approval inspections.
    • Participate as the lead inspector or as a member of an inspection team on pre-licensing and preapproval inspections for BLAs and supplements.Assess conformance to applicable FDA regulations (e.g., Current Good Manufacturing Practice For Finished Pharmaceuticals - 21 CFR 211 and 21 CFR 600) and standards.
    • Meet with representatives of the regulated industry and other sponsors of biological products or medical devices to discuss facility design, operation, manufacturing and compliance with GMPs.

    Travel Required

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

    Supervisory status

    No

    Promotion Potential

    13

  • Job family (Series)

    0696 Consumer Safety

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/493216200. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.