Hiring: Lead - Cell Biology Lab (Assistant Manager)

Bharat Serums and Vaccines; Poicha; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Bharat Serums and Vaccines is seeking a senior professional to lead the Cell Biology Laboratory operations in Gujarat. The role emphasizes cGMP compliance, audit readiness, and oversight of potency assays, ELISA, and cell culture activities to ensure reliable batch release and stability testing.

The ideal candidate will bring 8–12 years in regulated bioassay laboratories, strong leadership, and deep knowledge of regulatory requirements, data integrity, and CAPA-driven improvements.

Qualifications

• 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 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.

Responsibilities

• Lead day-to-day Cell Biology Laboratory operations ensuring 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

Skills

Cell biology

Bioassays

ELISA

Mammalian cell culture

Bioassay validation

Education

M.Sc. in Biotechnology/Biochemistry/Life Sciences

Tools

GraphPad Prism

MS Excel

PLA Software

Job description

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.