Senior Specialist Quality Control Analytical

Senior Specialist, Quality Control Analytical, Cell Therapy

Role Overview

The Senior Specialist, QC Analytical, provides operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability. 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 routine testing execution, laboratory operations management, quality record management, and audit/inspection readiness. The Senior Specialist 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.

Role Responsibilities

• 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 ).
• Laboratory operations oversight: Coordinate day‑to‑day QC lab activities including sample intake, scheduling, and testing flow.
• Capacity and scheduling management: Build testing schedules; balance priorities to meet lot release and stability timelines.
• 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
• Minimum of 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.
• 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.
• 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; 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 - $124,698.00 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.

Date Posted

07-May-2026

Closing Date

18-May-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.