Senior Quality Control Specialist for Cell Therapy

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time

We are seeking a Senior Quality Control Specialist to oversee contract lab testing and support safety testing for novel drug products targeting oncological indications. As a key member of our Quality Control team, you will be responsible for managing contract testing laboratories, overseeing sample collection and shipment, and reviewing test data to deliver results internally.

Key Responsibilities:

  • Manage contract testing laboratories for microbial testing of in-process and final product
  • Oversee sample collection, shipment, receiving, and reviewing test data to deliver results internally
  • Support the establishment of rapid microbial method testing for lot release of drug product to support internal clinical manufacturing
  • Support the Environmental Monitoring program for an internal manufacturing site
  • Provide expertise to support investigations, deviations, and CAPAs

Requirements:

  • Bachelor's degree and 5+ years of relevant experience
  • Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred
  • Experience with environmental monitoring, aseptic processing, and microbial testing
  • Strong understanding of cGMP/ICH/FDA/EU guidance and regulations relating to safety testing of biologics or cell and gene therapies

About Regeneron Cell Medicines:

Regeneron Cell Medicines has been created to advance the next generation of cell therapies and explore combinations with Regeneron's proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing, and clinical employees based in Seattle, WA and Cambridge, MA.



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