Manager Quality Control Analytical (Wednesday - Saturday)
About The Position
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.
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 to cross-functional stakeholders; experience presenting in audits/inspections.
- Hands-on experience 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.
- Effective cross-functional partner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in a fast-changing environment and adjusting plans to meet patient-critical timelines.
- Ability to work on-site in a lab-based role for the assigned shift.
Responsibilities
- Manage a QC laboratory team and day-to-day lab activities including sample intake, scheduling, testing flow and data review.
- 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+).
- 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.
- Train and coach junior team members on methods, cGMP/GDP, safety, and data integrity; support qualification of analysts and ongoing proficiency assessments.
- Coordinate testing schedules, sample logistics, and material controls; communicate status and risks; escalate issues proactively to meet lot release timelines.
- Drive 5S, visual management, standard work, and deviation trend reviews; improve flow and increase right-first-time performance.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Manager
