Senior QC Micro Specialist- Cell Therapy

1 month ago

Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time
Job Title: 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. As a Senior QC Micro Specialist, you 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:
  • Have a Bachelor's degree and 5+ years of relevant experience
  • Biopharmaceutical/industry experience in the cell and gene therapy space is strongly preferred
  • Must have 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 required
  • 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.

  • Senior Quality Control Specialist

    3 weeks ago

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

    Senior QC Micro Specialist - Cell Therapy Job DescriptionWe 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...

  • Senior Quality Control Specialist

    3 weeks ago

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

    Senior QC Micro Specialist - Cell Therapy Job DescriptionWe 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...

  • Senior Quality Control Specialist

    1 month ago

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

    Senior QC Micro Specialist - Cell TherapyWe are seeking a highly skilled Senior QC Micro Specialist to join our Quality Control team as part of our new Regeneron Cell Medicines group. 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...

  • Senior Quality Control Specialist

    1 month ago

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

    Senior QC Micro Specialist - Cell TherapyWe are seeking a highly skilled Senior QC Micro Specialist to join our Quality Control team as part of our new Regeneron Cell Medicines group. 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...

  • Senior Quality Control Specialist

    4 weeks ago

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

    Senior QC Micro Specialist- Cell Therapy Job DescriptionWe 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...

  • Senior Quality Control Specialist

    4 weeks ago

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

    Senior QC Micro Specialist- Cell Therapy Job DescriptionWe 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...

  • Senior Microbiologist Specialist

    2 weeks ago

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

    Senior QC Micro Specialist- Cell TherapyWe 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...

  • Senior Scientist

    4 weeks ago

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

    Join Our Team as a Senior Scientist - Cell TherapyWe are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine (RCM) mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs.Key...

  • Senior Scientist

    4 weeks ago

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

    Join Our Team as a Senior Scientist - Cell TherapyWe are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine (RCM) mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs.Key...

  • Senior Quality Control Specialist for Cell Therapy

    7 days 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...

  • Senior Quality Control Specialist for Cell Therapy

    1 week ago

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

    We are seeking a highly skilled Senior Quality Control Specialist to join our Quality Control team as part of our new Regeneron Cell Medicines group. As a Senior Quality Control Specialist, you will be responsible for overseeing contract lab testing and supporting safety testing for novel drug products targeting oncological indications. You will also play a...

  • Senior Scientist

    2 months ago

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

    **Job Summary**We are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine's mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs.**Key Responsibilities**Leverage molecular...

  • Senior Scientist

    2 months ago

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

    **Job Summary**We are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine's mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs.**Key Responsibilities**Leverage molecular...

  • Senior Research Associate

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Xap Therapeutics Full time

    About Xap TherapeuticsXap Therapeutics is a pioneering biopharmaceutical company dedicated to revolutionizing the field of genetic medicine. Our innovative platform leverages CRISPR technology to deliver genetic therapies in the bloodstream of patients, offering a new frontier in the treatment of genetic disorders, cancer, and autoimmunity.Job SummaryWe are...

  • Senior Research Associate

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Xap Therapeutics Full time

    About Xap TherapeuticsXap Therapeutics is a pioneering biopharmaceutical company dedicated to revolutionizing the field of genetic medicine. Our innovative platform leverages CRISPR technology to deliver genetic therapies in the bloodstream of patients, offering a new frontier in the treatment of genetic disorders, cancer, and autoimmunity.Job SummaryWe are...

  • Senior Researcher

    3 days ago

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

    Regeneron Pharmaceuticals, Inc. is seeking a highly skilled Senior Scientist to support the Regeneron Cell Medicine (RCM) mission to bring innovative cell therapy products to patients.Key Responsibilities:Leverage molecular biology techniques to design constructs, clone, and generate lentiviral vectors using proprietary platform technology.Design and carry...

  • Cell Therapy Manufacturing Expert

    2 months ago

    Cambridge, Cambridgeshire, United Kingdom TTP Full time

    {"title": "Cell Therapy Manufacturing Expert", "content": "Transforming Patient Access to Cell TherapiesAt TTP Group, we're revolutionizing the manufacturing of cell therapies to make them more accessible to patients. Our team is working on a robotic automation solution that combines aseptic fluid-handling technologies with advanced robotics to create a...

  • Cell Therapy Manufacturing Expert

    2 months ago

    Cambridge, Cambridgeshire, United Kingdom TTP Full time

    {"title": "Cell Therapy Manufacturing Expert", "content": "Transforming Patient Access to Cell TherapiesAt TTP Group, we're revolutionizing the manufacturing of cell therapies to make them more accessible to patients. Our team is working on a robotic automation solution that combines aseptic fluid-handling technologies with advanced robotics to create a...

  • Senior Cell Therapy Manufacturing Scientist

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Northreach Full time

    Process Development Scientist - Cell Therapy ManufacturingNorthreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages...

  • Senior Research Scientist

    2 weeks ago

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

    We are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine's mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs.Key Responsibilities:Leverage molecular biology...