QC Validation Specialist
Core
Validation and technology transfer of analytical test methods for gene therapy products and associated materials to ensure compliance with EU and FDA GMP requirements.
Role type
QC Validation Specialist
Builds
Validated analytical methods and SOPs for gene therapy manufacturing
Domain
Biopharmaceuticals / Gene Therapy
Required skills
Analytical method validation, GMP compliance, Data integrity, Protocol generation, Regulatory guidelines (ICH Q2(R1)), SOP development
Preferred skills
qPCR, HPLC (RP-HPLC/SEC), ELISA, SOS/Western blot, Cell-culture, DNA extraction, Microsoft Office
Responsibilities
Develop and validate analytical test methods for gene therapy products, Generate validation protocols and reports, Transfer validated methods to QC GMP labs, Maintain Quality Management System and document control, Perform routine assessment of analytical methods, Close GMP documentation (Issues, CAPAs, Change Controls)