QC Specialist
Core
Ensure GMP-compliant activities for the manufacture and release of plasmids and gene therapy products through routine testing, method validation, and stability studies.
Role type
Senior Quality Control Specialist (Gene Therapy/Plasmids)
Builds
Gene therapy and plasmid products
Domain
Biopharmaceuticals / Gene Therapy
Required skills
GMP compliance, HPLC/Capillary Electrophoresis/PCR/Cell culture assay development, stability study execution, CAPA management, data integrity, regulatory guidelines (cGMP, ICH, EMA, FDA, USP, EP), technical writing, investigation leadership
Preferred skills
Method transfer expertise, equipment qualification, cross-departmental collaboration, audit experience
Technologies
HPLC, Capillary Electrophoresis, PCR, Cell culture assays
Responsibilities
Execute routine in-process and release testing for gene therapy products; lead investigations into deviations, OOS, and OOTs; develop and validate analytical methods; support stability studies and method transfers; ensure GMP and data integrity compliance; prepare protocols and reports for regulatory activities.
Seniority
Senior, hands-on IC