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