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 onright‑first‑timeanalyticalassayexecution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and othercell‑basedassays)andend‑to‑endlaboratory readiness,includingpeople andequipmentoversight.Responsibilities spanroutine testing execution,laboratory operations management,quality 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, PCR,cell basedassays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+).

• Laboratory operations oversight: Coordinateday‑to‑dayQC 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 andincreaseright‑first‑timeperformance.

MinimumRequirements

• Bachelor’s 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 supply,phase‑appropriatecontrols).

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

• Hands‑onexperience 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.

• Effectivecross‑functionalpartner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in afast‑changingenvironment and adjusting plans to meetpatient‑criticaltimelines.

• 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 $83,132.00 - $124,698.00Our 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.