Role & responsibilities
- Responsible for executing upstream mammalian cell culture operations from vial revival to large-scale production as per cGMP.
- Operate and monitor single use bioreactors for seed expansion and production batches.
- Execute commercial, validation and PPQ batches in coordination with cross-functional teams.
- Perform in-process sampling and analysis, monitor critical parameters and ensure batch compliance.
- Handle cell culture media preparation, inoculum development, batch harvesting, centrifugation and reconditioning activities.
- Troubleshoot bioreactor/process equipment and support deviation management.
- Maintain BPCR, batch records, logbooks and equipment documentation.
- Participate in audit readiness activities including USFDA, EMEA and internal quality inspections.
📌 Senior Executive- Manufacturing (Upstream) (Pune)
🏢 Enzene
📍 Pune