Senior Specialist Quality Control Analytical

SeniorSpecialist Quality Control Analytical Cell Therapy

Role Overview

The Senior Specialist QCAnalytical provides operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability. The role focuses onrightfirsttimeanalyticalassayexecution (e.g. flow cytometry ELISA PCR automated cell counting and othercellbasedassays)andendtoendlaboratory readinessincludingpeople andequipmentoversight.Responsibilities spanroutine testing executionlaboratory operations managementquality record management and audit/inspection readiness. The Senior Specialist partners closely withother QC teams MSAT/Analytical Development Manufacturing QA and SupplyChainto ensure the laboperatessafely compliantly and efficiently to meet patient supply timelines.

Role Responsibilities

• 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).

• Laboratory operations oversight: CoordinatedaytodayQC lab activities including sample intake scheduling andtestingflow.

• Capacity and scheduling management: Build testing schedules; balance priorities to meet lot release and stability timelines.

• 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

• Minimum of5 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.

• Competence in leading investigations and implementing CAPAs; working knowledge of change control risk management and documentation practices aligned to cGMP and GDP.

• 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 role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines.This role will require occasional weekend support.

• Experience in cell therapy lot release and stability preferred.

The annual base pay for this position ranges from $ 83132.00 - $124698.00 Our positions offer eligibility for various incentivesan 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.