Senior Executive

Enzene Biosciences Ltd; Pune District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Enzene Biosciences Ltd in India seeks a skilled bioprocess operator to execute upstream mammalian cell culture operations from vial revival to large-scale production in conformance with cGMP.

You will operate single-use bioreactors for seed expansion and production batches, handle media preparation, inoculum development, batch harvesting and in-process sampling while ensuring batch compliance and audit readiness.

Responsibilities

• Execute 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.

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.