Senior Specialist QC Microbiology Cell Therapy
Core
Support QC testing for in-process, final product, and stability samples, plus environmental and facility monitoring for cell therapy manufacturing.
Role type
Senior Specialist QC Microbiology Cell Therapy
Builds
In-process, final product, and stability samples for cell therapy medicines
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Required skills
Microbiological testing, cGMP compliance, Method validation, Data verification, CAPA management, Technical writing, Problem-solving, GMP documentation review, Training and mentoring
Preferred skills
LIMS, ELN, Laboratory data analysis systems
Responsibilities
Perform routine testing of in-process, final product, and stability samples; Perform environmental/facilities monitoring and microbiological testing; Execute method transfer/verification/validation; Perform data review and GMP documentation review; Lead CAPA, deviation, and investigation tasks; Train and mentor others on QC test methods.
Seniority
Senior, hands-on IC