Senior Specialist, QC Analytical, Cell Therapy
Core
Support QC testing for in-process, final product, and stability samples in a cell therapy environment, including data review, method troubleshooting, and validation.
Role type
Senior Specialist, QC Analytical (Cell Therapy)
Builds
In-process, final product, and stability samples for cell therapy medicines
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
cGMP compliance, method transfer/validation, data verification, technical writing, problem-solving, GMP documentation review, CAPA/deviation management, training/mentoring
Preferred skills
LIMS, ELN, laboratory data analysis systems
Responsibilities
Perform routine testing of in-process, final product, and stability samples; execute method troubleshooting and validation; perform data verification and GMP documentation review; manage document revisions, projects, CAPA, and deviations; train and mentor others on QC test methods and procedures
Seniority
Senior, hands-on IC