Manager Quality Control Analytical (Sunday-Wednesday)

The Manager, Quality Control 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:

• 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 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.