Supervisor, QC Microbiology

Role: Supervisor, QC Microbiology supporting cell therapy manufacturing within Legend Biotech's Quality Operations in Raritan, NJ. Primary objectives include supervising microbiology laboratory workflows, ensuring compliance with cGMP, and supporting microbiological testing for raw materials, in-process, environmental, and product release. Responsibilities encompass staff training, equipment maintenance, test method validation, investigations of non-conformances, and contributing to QC strategy aligned with regulatory standards. Requirements: Bachelor's in Science or related field; 6+ years in microbiology/QC, preferably in aseptic or cell therapy settings; minimum 1 year of leadership experience; solid knowledge of microbiological principles, cGMP, and regulatory guidelines (FDA/EU). Preferred: experience in clinical quality, method development, cell banking, or R&D. High-value biopharma specifics include expertise in cell therapy (autologous/allogeneic), GMP compliance, and involvement in QC microbiology supporting innovative biologics manufacturing. Collaboration spans Quality Assurance, Manufacturing, Engineering, and Technical Operations. Work setup is onsite with occasional travel to partner sites; flexibility for overtime as needed. The role demands excellent communication skills, organizational ability, and comfort interacting with inspectors, with a focus on maintaining compliance and supporting advanced cell therapy production.