Lead- QC (biologics) in भारत

Key Responsibilities:

• Lead QC, Analytical and Bioassay departments.
• 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.

• 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.