Senior Quality Control Scientist

2 weeks ago

United Kingdom Northreach Full time

Role Overview:

We are looking for an experienced and highly motivated Senior Quality Control (QC) Scientist to lead and contribute to the quality control activities within our state-of-the-art cell and gene therapy manufacturing facility. This role is critical in ensuring that our innovative therapies meet the highest standards of quality and compliance, particularly in a GMP-regulated environment. The successful candidate will have a deep understanding of the unique challenges and regulatory requirements associated with cell and gene therapies, including Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP).

Key Responsibilities:

  • Lead QC Operations: Oversee and manage daily QC testing, including GMP-compliant batch release and stability testing, ensuring that all processes meet rigorous quality standards.
  • Support Clinical Manufacturing: Provide comprehensive QC testing support for clinical trial manufacturing, utilizing techniques such as microbiology, mammalian cell culture, flow cytometry, qPCR, and potency testing specific to cell and gene therapies.
  • Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including handling out-of-specification (OOS) results, deviations, and change controls.
  • Method and Equipment Validation: Assist in the qualification and validation of test methods, processes, and equipment to ensure their reliability and suitability for use in clinical manufacturing.
  • Documentation and Reporting: Maintain strict adherence to Good Documentation Practices (GDP) by meticulously recording data and authoring detailed reports.
  • Laboratory Management: Contribute to the selection, qualification, and maintenance of QC laboratory equipment and materials, ensuring readiness and compliance for clinical manufacturing activities.
  • Technology Transfer: Lead the transfer of QC test methods from the Analytical Development Group to the QC laboratory, ensuring smooth integration and operational efficiency.
  • Stability Programs: Oversee and support QC stability programs, ensuring ongoing compliance and high-quality outcomes.
  • SOP and Regulatory Documentation: Assist in the creation and review of Standard Operating Procedures (SOPs), technical reports, and other regulatory documents as required.
  • Health and Safety: Uphold and enforce the highest standards of health and safety within the laboratory, adhering to all company guidelines.

Required Experience and Skills:

  • Essential:
  • Extensive experience working in a GMP QC laboratory, with a focus on cell and gene therapy products.
  • Strong knowledge of pharmaceutical GMP regulations and their application in a clinical manufacturing environment.
  • Experience with key biopharmaceutical and cell-based techniques, including aseptic technique, sterility testing, cell counting, flow cytometry, PCR, mammalian cell culture, and potency testing.
  • Exceptional organizational skills, with the ability to present complex data clearly and logically.
  • High attention to detail and commitment to maintaining the highest quality standards.
  • Ability to work both independently and collaboratively within a multidisciplinary team.

  • Preferred:
  • Experience in a fast-paced laboratory environment, particularly in the biotechnology or pharmaceutical industry.
  • Understanding of critical process parameters (CPP) and critical quality attributes (CQA) related to the manufacturing processes of cell and gene therapies.
  • Experience in the qualification of assays (aligned with ICH guidelines) for batch release and stability testing of cell and gene therapy products.

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