Senior Quality Control Scientist

Northreach is a dynamic recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. 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.

Position Summary

The Senior Quality Control Scientist will be instrumental in leading the daily operations of our Quality Control Laboratories. Reporting to a Principal Scientist, this role requires a highly skilled and motivated individual with extensive experience in Quality Control within the cell therapy sector. The ideal candidate will have a deep understanding of regulatory requirements and a proven ability to manage the operational dynamics of a busy QC laboratory, including supporting stability assessments and validating phase-appropriate assays for clinical manufacturing.

Key Responsibilities

• Lead and oversee QC testing for clinical trial manufacturing across multiple disciplines, including microbiology, mammalian cell culture, flow cytometry, qPCR, and potency testing.
• Manage quality actions related to QC activities, such as Invalid Assays, Root Cause Analysis (RCA), Out-of-Specifications (OOS), Deviations, and Change Controls.
• Direct the qualification and validation of test methods and processes, ensuring their suitability for clinical trial manufacturing support.
• Ensure adherence to Good Documentation Practices (GDP) in all data recording and report authoring.
• Select and procure appropriate QC laboratory equipment, ensuring compliance with all regulatory standards.
• Oversee equipment qualification initiatives and lead efforts to streamline QC operations.
• Collaborate with the Technology Transfer team to facilitate the transfer of QC test methods from the Analytical Development Group.
• Design and execute comprehensive QC stability programs.
• Promote and implement best practices within the department, mentoring and training junior staff members to enhance their skills and knowledge.
• Coordinate closely with Analytical Development and Quality Assurance to ensure the timely completion of objectives.
• Author Standard Operating Procedures (SOPs), reports, and regulatory documentation, including CMC modules, as required.
• Perform additional duties as necessary, following consultation (e.g., Quality Council representative).
• Adhere to all health and safety guidelines provided by the company.

Qualifications

• Extensive experience in a relevant biotechnology or pharmaceutical environment (Essential).
• Proven ability to thrive in a fast-paced laboratory setting (Preferred).
• Doctorate or MD/Ph.D. in a relevant scientific discipline, Master’s degree or equivalent with 8+ years of directly related experience; or Bachelor’s degree in a scientific discipline with 10+ years of experience (Essential).
• Expertise in phase-appropriate analytical method transfer, qualification, and validation (ICH) for batch release and stability testing of cell-based therapies (Essential).
• Experience designing and implementing phase-appropriate stability studies (Essential).
• Strong understanding of critical process parameters (CPP), critical quality attributes (CQA), and comparability concerning manufacturing processes (Essential).
• Proficiency with a range of biopharmaceutical and cell-based techniques, including aseptic techniques, sterility testing, cell counting, flow cytometry, PCR, mammalian cell culture, and potency testing (Essential).
• In-depth knowledge of cell biology and immunology (Essential).
• Exceptional verbal and written communication skills (Essential).
• Highly self-motivated, adaptable, and focused on team success (Essential).
• Thorough understanding of GMP regulations (Essential).

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.