Senior Microbiologist Specialist

2 weeks ago


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

We are seeking a highly skilled and experienced Senior QC Micro Specialist to join our Quality Control team as a part of our new Regeneron Cell Medicines group. This role 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 including 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 set up, management, and maintaining the Environmental Monitoring program for an internal manufacturing site
  • Support all aspects for 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
  • 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
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
  • Leading activities in microbiology laboratories that support sterile manufacturing

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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