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Quality Site Head

Company: Fpc Of Atlanta
Location: Levittown
Posted on: January 12, 2022

Job Description:

Ready to expand a site and Quality team in a dynamic biopharmaceutical company? Your Quality leadership will be applied while further building out site Quality operations, drug product capacity, new QC labs processes, and an Analytical Method Development team. Additional responsibilities include:

  • QA, QC, Compliance and testing leadership in both large molecule and small molecule operations
  • Staff development and training. Included here is GMP procedures and phase appropriate Quality practices
  • Lead tech xfer of test methods to QC lab for release of raw materials, in-process materials, intermediates, APIs and finished products
  • Batch review oversight
  • CMC input for IND and IMPD submissions for Drug Substance, Drug Products and stability studies
  • Failure analysis, problem solving, and risk assessment and mitigation activities for GMP facility, equipment and related validation
    Qualifications include:
    • B.S. or higher degree in Scientific discipline
    • 10+ year experience with biologics, biopharmaceuticals or sterile pharmaceuticals
    • 4+ years managerial experience
    • Strong leadership, training and motivational capabilities as well as the understanding of how important it is to develop people and create career paths for them.
    • Early phase GMP experience required and knowledge in all aspects of product development from investigational phase to commercial launch preferred.
    • Depth with QC, method development, tech transfer, phase appropriate processes and Analytical validation
    • CMC strengths
    • Broad knowledge of drug developmentby Jobble

Keywords: Fpc Of Atlanta, Levittown , Quality Site Head, Other , Levittown, Pennsylvania

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