Associate, Quality Control Analytical, Cell Therapy

Associate, Quality Control Analytical, Cell Therapy 

Role Overview 

The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, completing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. 

Role Responsibilities 

• Routine analytical testing: Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations. 

• Sample and reagent preparation: Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs. 

• Instrument operation: Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance. 

• Documentation and data integrity: Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles. 

• Lab support and readiness: Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes. 

• Quality systems participation: Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls. 

• Training and qualification: Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning. 

• Collaboration and communication: Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines. 

Role Requirements 

• Foundational technical skills: Basic hands-on experience with laboratory techniques relevant to cell therapy or biologics (e.g., pipetting, aseptic technique, ELISA basics, PCR setup, cell counting/viability). 

• cGMP and GDP awareness: Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions. 

• Organization and attention to detail: Strong focus on right-first-time execution, accurate record-keeping, and timely response to escalation of discrepancies. 

• Collaboration and attitude: Demonstrates effective cross-functional collaboration, accepts flexibility in a constantly evolving environment, and maintains a positive, solutions oriented attitude to drive outcomes. 

• Growth mindset: Enthusiasm to develop new technical skills and expand responsibilities with experience. 

• Scheduling: Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines. 

 Minimum Requirements:  

Education: 

•  Associate’s degree with relevant lab experience may be considered. 

• Preferred: Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.  

Experience: 

• Industry/academic experience: At least one year of laboratory experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus. 

The annual base pay for this position ranges from $ 63,320.00 - $94,980.00  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

24-Jan-2026

Closing Date

01-Feb-2026Our 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.