Specialist, QC Analytical, Cell Therapy
Core
Perform routine QC testing for in-process, final product, and stability samples in a cell therapy manufacturing environment.
Role type
QC Analytical Specialist (Cell Therapy)
Builds
In-process, final product, and stability samples for cell and gene therapy medicines
Domain
Biopharmaceuticals / Cell Therapy / GMP
Required skills
cGMP compliance, cell-based assays, flow cytometry, qPCR, ELISA, aseptic technique, LIMS, ELN, data verification, GMP documentation review, CAPA, deviation investigation
Preferred skills
Method transfer/validation, technical writing, continuous improvement
Technologies
LIMS, ELN
Responsibilities
Perform routine testing of in-process, final product, and stability samples; Perform testing for method transfer/validation/verification; Perform data verification, data review and review of GMP documentation; Train analysts on general job duties
Seniority
Mid-level, hands-on IC