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Quality Control Scientist

2 months ago

London, United Kingdom Northreach Full time

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Overview:

We are seeking a dedicated Quality Control Scientist I to contribute to the efficient daily operations of Quality Control Laboratories. Reporting to the Scientist II/Principal Scientist, the ideal candidate will be a motivated professional with a background in Quality Control within the cell therapy sector. This role requires an in-depth understanding of regulatory requirements and the ability to support stability assessments, transfer, and validation of phase-appropriate assays for clinical manufacturing.

Key Responsibilities:

  • Conduct QC testing across multiple disciplines, including microbiology, mammalian cell culture, flow cytometry, qPCR, and potency testing to support clinical trial manufacturing.
  • Initiate and manage quality actions related to QC activities, such as Invalid Assay, Root Cause Analysis (RCA), Out of Specification (OOS), Deviations, and Change Controls.
  • Oversee the qualification and validation of test methods and processes to ensure their suitability for clinical trial manufacturing.
  • Maintain Good Documentation Practices (GDP) when recording data and authoring reports.
  • Assist in the selection and procurement of appropriate QC laboratory equipment.
  • Participate in equipment qualification activities.
  • Support the technology transfer of QC test methods from the Analytical Development Group.
  • Contribute to QC stability programs.
  • Promote best practices within the department and mentor junior staff members.
  • Ensure GMP compliance and advocate for GMP principles, such as "right first time."
  • Collaborate closely with Analytical Development and QA to achieve timely completion of objectives.
  • Author Standard Operating Procedures (SOPs), reports, and regulatory documents, including CMC modules as needed.

Skills and Competencies:

Essential:

  • Direct experience in the biotechnology or pharmaceutical industry.
  • Ph.D., MD/Ph.D., or equivalent in a relevant scientific discipline, or a Master’s degree with 5+ years of related experience, or a Bachelor’s degree with 7+ years of experience.
  • Proficiency in phase-appropriate analytical method transfer, qualification, and validation (ICH) for cell-based therapy batch release and stability testing.
  • Expertise with biopharmaceutical and cell-based techniques such as aseptic technique, sterility testing, cell counting, flow cytometry, PCR, mammalian cell culture, and potency testing.
  • Comprehensive understanding of cell biology and immunology.
  • Strong verbal and written communication skills.
  • Flexibility, self-motivation, and a focus on team outcomes.
  • Thorough knowledge of GMP regulations.

Preferred:

  • Experience working in a busy laboratory environment.
  • Understanding of critical process parameters (CPP), critical quality attributes (CQA), and comparability in manufacturing processes.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.