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