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Manager, Quality Control

Department: QC
Location: Cambridge, MA

The QC Manager will provide oversight of routine QC activities related to drug substance and drug product testing, bioassay test procedure for innovative microbiome based products.  Additionally, the Manager will ensure the scheduling and data report out for all critical testing. The Manager will support staff development.

Job Responsibilities:

  • Oversee testing and data review in support of drug substance and drug product programs using a variety of standard and proprietary-based bioassay methods.
  • Prioritization of activities
  • Lead laboratory investigations as required and ensuring that testing is performed promptly, accurately, and efficiently.
  • Resolution of technical and compliance activities
  • Analyze and interpret data.
  • Routinely report QC function metrics.
  • Other duties include but are not limited to membership on cross functional, strategic teams, assisting with reagent preparation and completion of associated documentation, and maintenance of freezers, refrigerators, stability chambers, and balances per applicable SOPís.
  • Supporting the QC Director in developing strategies for growth and development of the GMP and testing programs.
  • Influence, coach, and educate junior staff and scientists on how to create an inclusive, forward-thinking and calibrated QC culture

Job Requirements:

  • A Bachelorís degree in Microbiology, Molecular, Biochemistry or other related scientific discipline is required as well as >10 years related work experience
  • GMP QC environment experience with extensive familiarity with current regulations (FDA, EU, ICH etc.)
  • Should be able to work independently and have good judgment and organizational skills.  
  • Must have strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management.

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