ManagerQualityControlAnalytical

Manager, Quality Control Analytical, Cell Therapy **Wednesday - Saturday (4x 10 hour day shift)** **Role Overview** The Manager, QC Analytical, provides managerial, operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing. The role focuses on right‑first‑time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell‑based assays) and end‑to‑end laboratory readiness, including people and equipment oversight. Responsibilities span management of a routine testing team, testing execution, laboratory operations management, quality record management, and audit/inspection readiness. The Manager partners closely with other QC teams, MSAT/Analytical Development, Manufacturing, QA, and Supply Chain to ensure the lab operates safely, compliantly, and efficiently to meet patient supply timelines. **This position is for a 4 days per week, 10 hours per day shift, Wednesday through Saturday.** **Role Responsibilities** * **Laboratory operations oversight** : Manage a QC laboratory team and day‑to‑day lab activities including sample intake, scheduling, testing flow and data review. * **Analytical testing:** Perform and oversee QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+). * **Documentation and compliance:** Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs, test methods, and certificates of analysis; ensure readiness for internal/external audits and regulatory inspections. * **Training and mentoring:** Train and coach junior team members on methods, cGMP/GDP, safety, and data integrity; support qualification of analysts and ongoing proficiency assessments. * **Planning and communication:** Coordinate testing schedules, sample logistics, and material contro