Quality Control Supervisor - Cell Therapy
On-sitePearland, Texas, United States
Job Summary
Quality Control Supervisor - Cell Therapy on-site in Pearland, TX, supervises QC Cell Therapy laboratory operations, including oversight of personnel, assays, and equipment to support production, release, and distribution of cell therapy products. Ensures testing activities comply with cGMP and collaborates with Quality Assurance and Operations. Responsible for leading, coaching, and mentoring staff; developing and monitoring QC capacity; writing and approving SOPs, protocols, sampling plans, and specifications; supporting audits, deviations, CAPAs, and customer complaints; leading technical investigations; and partnering with QA, Program Management, and Operations. Requires a Bachelor’s degree in a scientific/STEM field (Master’s preferred) with 5–10 years in cell therapy or related industry; knowledge of ddPCR, ELISA, cell count and viability, CBC, potency/culture assays; experience with assay qualification/validation and tech transfer; familiarity with LIMS, TrackWise, and SAP; and proven leadership in a regulated lab with cGMP experience. The role includes the AM shift (Wednesday – Saturday, 6:00 AM – 4:30 PM) with weekend shift differentials and on-site work in Pearland, TX, Lonza context, and associated benefits.
Required Qualifications
- Bachelor’s degree in a scientific/STEM field required
- Master’s degree preferred
- 5–10 years of relevant experience in cell therapy or related industry
- Knowledge of biological and cell-based assays (ddPCR, ELISA, cell count and viability, CBC, potency/culture assays)
- Experience with assay qualification, validation, and technology transfer
- Experience with document management systems (LIMS, TrackWise, SAP)
- Leadership or supervisory experience in a regulated laboratory environment
- Strong understanding of cGMP practices and quality systems
- Strong communication, problem-solving, and cross-functional collaboration skills
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