Senior Executive

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a skilled professional to manage upstream mammalian cell culture operations from vial revival to large-scale production, ensuring cGMP compliance and batch integrity.

The role involves operating single-use bioreactors for seed expansion and production, and coordinating with cross-functional teams for commercial, validation, and PPQ batches. Responsibilities include in-process sampling, parameter monitoring, media prep, inoculum development, harvest, and

Responsibilities

• Upstream mammalian cell culture operations from vial revival to large-scale production per cGMP.
• Operate and monitor single-use bioreactors for seed expansion and production batches.
• Execute commercial, validation and PPQ batches coordinating with cross-functional teams.
• Perform in-process sampling, monitor critical parameters and ensure batch compliance.
• Handle cell culture media preparation, inoculum development, batch harvesting, centrifugation and reconditioning.
• 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.

Job description

• 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.