Hiring: Lead - Cell Biology Lab (Assistant Manager)

Role & responsibilities

• Lead day-to-day Cell Biology Laboratory operations and ensure cGMP compliance and audit readiness.
• Execute and oversee cell-based potency assays, ELISA, cell culture, batch release, and stability testing.
• Manage laboratory equipment qualification, calibration, and lifecycle activities.
• Review and approve SOPs, STPs, protocols, and laboratory documentation.
• Support method transfer, validation, and troubleshooting of bioassays.
• Investigate assay failures, deviations, OOS/OOT results, and implement CAPAs.
• Train and mentor team members while driving operational excellence and regulatory compliance

Preferred candidate profile

• M.Sc. in Biotechnology, Biochemistry, or Life Sciences with 8-12 years of experience in Cell Biology and Bioassay Laboratories.
• Strong expertise in cell-based potency assays, ELISA, mammalian cell culture, and bioassay method validation.
• Hands-on experience in handling adherent and suspension cell lines, cell banking, and routine cell culture maintenance.
• Proficient in GraphPad Prism, PLA Software, and MS Excel for statistical analysis and data interpretation.
• Strong understanding of cGMP, GLP, Data Integrity, and global regulatory requirements.
• Experienced in laboratory investigations, OOS/OOT handling, deviation management, and CAPA implementation.
• Demonstrated leadership, mentoring, and cross-functional collaboration skills in regulated environments.