Manager Quality Control Analytical (Sunday-Wednesday)

Manager Quality Control Analytical Cell Therapy

Sunday - Wednesday(4x 10 hour day shift)

Role Overview

TheManager QCAnalytical providesmanagerialoperationaland 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 readinessincludingpeople andequipmentoversight.Responsibilities spanmanagement ofa routine testing teamtesting executionlaboratory operations managementquality 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 shiftSunday through Wednesday.

Role Responsibilities

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

• Analytical testing:Perform and oversee QC testing for cell therapy products (flow cytometry ELISA PCRcell 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

• Bachelors 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 supplyphaseappropriatecontrols).

• 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.