Manager Quality Control Analytical (Sunday-Wednesday)

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.
• Date Posted
• 05-Jun-2026
• Closing Date

Benefits

Additional Information

Manager , Quality Control Analytical , Cell Therapy Sunday - Wednesday (4x 10 hour day shift) Role Overview The Manager , QC A nalytical , 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 hour s per day shift , Sunday through Wednesday .

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