cGMP Quality Control (QC) Specialist
Core
Design, develop, evaluate, and implement quality control testing, assays, and procedures for biologics and cell/gene therapy products in a cGMP facility.
Role type
Quality Control Specialist (cGMP)
Builds
Biologics and cell/gene therapy products for internal/external university users
Domain
Biopharmaceuticals / Cell and Gene Therapy
Required skills
cGMP compliance, batch release testing, aseptic techniques, clean room operations, instrumentation operation (cell counters, bioreactors, centrifuges), SOP development, troubleshooting, leadership
Preferred skills
Master's degree in biotechnology, 5+ years experience in cellular/biological manufacturing, advanced problem-solving
Technologies
Cell counters, bioreactors, centrifuges, biological safety cabinets
Responsibilities
Perform cGMP batch release testing; Operate instrumentation for cell and gene therapy manufacturing; Maintain confidentiality for patient identification and specimen verification; Supervise junior staff; Improve current methods and evaluate innovative techniques in quality control testing
Seniority
Mid-level, hands-on IC with supervisory duties