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Manager, Quality Control Analytical, Cell Therapy

Wednesday - Saturday (4x 10 hour day shift)

Role Overview

TheManager, QCAnalytical, providesmanagerial,operationaland technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stabilitytesting. The role focuses onrightfirsttimeanalyticalassayexecution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and othercellbasedassays)andendtoendlaboratory readiness,includingpeople andequipmentoversight.Responsibilities spanmanagement ofa routine testing team,testing execution,laboratory operations management,quality record management, and audit/inspection readiness. TheManagerpartners closely withother QC teams, MSAT/Analytical Development, Manufacturing, QA, and SupplyChainto ensure the laboperatessafely, compliantly, and efficiently to meet patient supply timelines.

This positionisfora4days per week, 10 hoursper day shift, Wednesday through Saturday.

Role Responsibilities

• Laboratory operations oversight:Manage a QC laboratory team anddaytodaylab activities including sample intake, scheduling,testingflowand data review.

• Analytical testing:Perform and oversee QC testing for cell therapy products (flow cytometry, ELISA, PCR,cell basedassays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+).

• Documentation and compliance:Maintainaccurate, contemporaneous recordsin 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 ongoingproficiencyassessments.

• Planning and communication:Coordinate testing schedules, samplelogistics, 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; improveflow andincreaserightfirsttimeperformance.

MinimumRequirements

• 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 experienceoperatinga 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,phaseappropriatecontrols).

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

• Handsonexperience 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.

• Effectivecrossfunctionalpartner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in afastchangingenvironment and adjusting plans to meetpatientcriticaltimelines.

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

The annual base pay (or hourly rate of compensation) for this position ranges from $112,604.80 - $168,907.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.