Clinical Research Coordinator II – Cellular Manufacturing
Core
Manufacture clinical-grade cellular therapies and vaccines for Phase I–III clinical trials in a cGMP facility.
Role type
Cellular Manufacturing Specialist (cGMP)
Builds
Clinical-grade cell-based products and vaccines for patient treatment
Domain
Biotechnology / Cellular Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aseptic technique, ISO 7 cleanroom operations, cell processing, analytical assays, SOP execution, batch record documentation, equipment troubleshooting, inventory management, regulatory compliance (cGMP/GxP)
Preferred skills
immunology, biochemistry, molecular biology, microbiology, viral gene transduction, sterile filling techniques, 21 CFR Parts 210/211 knowledge
Technologies
Microsoft Office Suite
Responsibilities
Perform cellular product processing and infusion procedures under GxP guidelines, execute SOPs for facility operations, manage inventory and materials, support deviation investigations and CAPA, train junior staff, document instrumentation errors and quality events, perform room changeovers and specialized cleaning
Seniority
Mid-level Individual Contributor