Clinical Research Coordinator II – Cellular Manufacturing
Core
Execute aseptic processing and complex protocol-driven manufacturing procedures for clinical-grade cellular therapies and vaccines in an ISO 7 cleanroom to support Phase I–III clinical trials.
Role type
Senior IC cellular manufacturing specialist (cGMP)
Builds
Clinical-grade cell-based products, vaccines, and reagents for patient treatment
Domain
Biopharmaceuticals / Cellular Therapy / cGMP Manufacturing
Required skills
Aseptic technique, ISO 7 gowning, cell processing, analytical assays, SOP execution, batch record documentation, deviation investigation, CAPA management, equipment qualification (IQ/OQ/PQ), inventory management, regulatory compliance (21 CFR 1271, 210, 211)
Preferred skills
Immunology, biochemistry, molecular biology, microbiology, viral gene transduction, sterile filling techniques, Microsoft Office Suite, Medical Lab Technician (MLT) or Pharmacy Technician (CPhT) certification
Technologies
LIMS, GxP compliant software, cell culture equipment, analytical instruments
Responsibilities
Perform cellular product processing and infusion procedures under GxP guidelines; execute SOPs for facility operations; support validation and qualification of processes and equipment; manage inventory and supply ordering; train junior staff; document deviations and quality events; transport products to clinics; perform room changeovers and specialized cleaning.
Seniority
Mid-level IC (2-5 years experience)