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.
- Solid 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.

📌 Hiring: Lead - Cell Biology Lab (Assistant Manager) (Vadodara)
🏢 Bharat Serums and Vaccines
📍 Vadodara