Senior Quality Control Specialist

3 days ago

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

Job Summary

We are seeking a highly skilled Senior Quality Control Specialist to join our Quality Control team at Regeneron Pharmaceuticals, Inc. as a part of our new Cell Therapy group. The successful candidate will be responsible for overseeing contract lab testing and supporting safety testing for novel drug products targeting oncological indications.

Key Responsibilities

  • Manage the contract testing laboratory for microbial testing of in-process and final product
  • Oversee sample collection, shipment, receiving, and reviewing test data, and deliver the 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 set up, 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 Certificates of Testing
  • Provide expertise to support investigations, deviations, and CAPAs
  • Implement process improvements to support operational efficiencies
  • Promote a culture of Quality and Operational excellence

Requirements

  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external)
  • Demonstrated leadership within teams producing results
  • Ability to communicate effectively in a way that fosters positive relationship building
  • Passion for addressing the critical unmet medical needs of patients
  • Self-directed individual who can work in a risk-tolerant, fast-paced, innovative environment

Education and Experience

  • Bachelor's degree in a relevant field (e.g., Microbiology, Biology, Chemistry)
  • At least 5 years of relevant experience in the biopharmaceutical industry, with a strong understanding of cGMP/ICH/FDA/EU guidance and regulations relating to safety testing of biologics or cell and gene therapies
  • Experience in site start-up operations is a plus

About Regeneron Cell Medicines

Regeneron Cell Medicines (RCM) 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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