Specialist, QC Analytical, Cell Therapy
Core
Perform routine QC testing, data verification, and documentation review for in-process, final product, and stability samples in a cell therapy manufacturing environment.
Role type
Specialist, QC Analytical (Cell Therapy)
Builds
In-process, final product, and stability samples for cell therapy medicines
Domain
Biopharmaceuticals / Cell Therapy / GMP
Required skills
cGMP compliance, cell and molecular biology techniques, aseptic technique, flow cytometry, qPCR, ELISA, data verification, GMP documentation review
Preferred skills
LIMS, ELN, technical writing, method transfer/validation
Technologies
LIMS, ELN, Biosafety Level 2 (BSL-2) equipment
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; Assist with deviations, investigations, and continuous improvement efforts
Seniority
Specialist, hands-on IC