• Filling and Formulation Manager, Head

    Job Locations US-MD-Silver Spring
    # of Openings
    1
    Type
    Regular Full-Time
  • Overview

    CAMRIS International is an medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

     

    CAMRIS is seeking a Filling and Formulation Manager who will be responsible for all filling operations at a Bioproduction Facility in Silver Spring, MD.  All bulk vaccines will be scheduled for filling in vials using either an automatic filling machine or by semiautomatic/manual filling protocols.  Products may also require freeze-drying as part of the protocol.  The filling room is a certified Class 100 clean room that requires decontamination and environmental monitoring on a routine basis.  The Manager must ensure that all products that are filled into final containers for use in humans meet all specifications for safety, potency, and efficacy.

    Responsibilities

    • Responsible for scheduling of products that require filling and freeze-drying.
    • Operate and provide non-contract maintenance of the filling machines, freeze-dryer, and sterilization equipment.
    • Provide preparation of all glassware, reagents, and materials that are used for a filling operation.
    • Prepare a Batch Production Record (BPR) for each fill (and listed as the Principal Investigator on this record).
    • Provide procurement of labels for the product being filled and completion of all data required for the fill.
    • Develop freeze-drying processes by experimentally determining optimal parameters for particular products.

    Qualifications

    • A minimum of five years’ experience in filling of parenteral products under GMP conditions.
    • Microbiology laboratory experience with knowledge of freeze-drying of bacteria and viruses.
    • Knowledge of GMP regulations pertaining to vaccines.
    • All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).

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