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Senior Quality Control Specialist

1 month ago

Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time
Senior QC Micro Specialist- Cell Therapy Job Description

We are seeking a highly skilled Senior QC Micro Specialist to join our Quality Control team at Regeneron Cell Medicines. As a key member of our team, you will be responsible for overseeing contract lab testing and supporting safety testing for novel drug products targeting oncological indications.

Key Responsibilities:
  • Manage contract testing laboratory for microbial testing of in-process and final product
  • Oversee sample collection, shipment, receiving, and reviewing test data, and deliver results internally
  • Oversee environmental monitoring contractors for manufacturing suites, ensuring samples are collected at determined frequency, receiving results of sampling, and delivering results internally
  • Support the establishment of rapid microbial method testing for lot release of drug product to support internal clinical manufacturing
  • Support the setup, management, and maintenance of the Environmental Monitoring program for an internal manufacturing site
  • Support all aspects of microbial testing, from sample receipt and chain of custody through generation of CoTs
  • Provide expertise to support investigations, deviations, and CAPAs
  • Implement process improvements to support operational efficiencies
Requirements:
  • Highly collaborative team player with excellent communication skills
  • Demonstrated leadership within teams producing results
  • Ability to communicate effectively in a way that fosters positive relationship building
  • Passion for addressing critical unmet medical needs of patients
  • Self-directed individual who can work in a risk-tolerant, fast-paced, innovative environment
Preferred Qualifications:
  • Biopharmaceutical/industry experience in the cell and gene therapy space
  • 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

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.