Oversee testing of raw materials, in-process samples, drug substances and finished biologics products.
Ensure analytical method validation, method transfer and stability studies.
Manage bioassay, potency testing and analytical activities.
Ensure compliance with cGMP, SOPs and data integrity requirements.
Review OOS/OOT investigations, deviations, CAPA and change controls.
Support regulatory audits and inspections.
Coordinate with QA, Production, R&D and other cross-functional teams.
Manage laboratory instruments, team training and performance.
Qualification:
M.Sc. / M.Pharm. / M.Tech. in Biotechnology, Biochemistry, Microbiology, Analytical Chemistry or a related life-sciences discipline.
12–18 years of relevant experience in Quality Control within biologics/biopharmaceutical manufacturing, with leadership experience across multiple QC laboratory functions.
Hands-on understanding of biologics analytical testing and bioassay/potency methods, GMP laboratory systems, investigations and regulatory inspection readiness.