Manager, Quality Control Analytical, Cell Therapy

Sunday - Wednesday(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, Sunday through Wednesday.  

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 controls; communicate status and risks; escalate issues proactively to meet lot release timelines. 

• Continuous improvement and LEAN: Drive 5S, visual management, standard work, and deviation trend reviews; improve flow and increase right‑first‑time performance. 

Minimum Requirements 

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline; advanced degree (MS/PhD) preferred. 

• At least 5 years' experience in pharmaceutical/biotech QC with emphasis on laboratory operations/management in a cGMP setting.   

• Demonstrated experience operating a QC laboratory in a regulated environment with knowledge of cell therapy specific considerations (e.g., chain of identity/chain of custody, rapid turnaround for patient supply, phase‑appropriate controls). 

• Proven ability to plan and coordinate laboratory operations, manage competing priorities, and communicate status, risks, and mitigations tocross‑functionalstakeholders; experience presenting in audits/inspections.

• Hands‑onexperience with qualification and maintenance of key QC instruments and with lab informatics (LIMS/ELN/LES, instrument data systems); strong command of data integrity controls and computerized systems compliance.

• Ability to design and deliver effective training; mentor analysts on safe, compliant, and efficient lab practices; cultivate a culture of quality and continuous improvement.

• Effectivecross‑functionalpartner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in a fast‑changingenvironment and adjusting plans to meet patient‑criticaltimelines.

• Ability to work on-site in a lab-based rolefor the assigned shift.