Senior Executive

Enzenespherenet; Pune District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Enzenespherenet is seeking a skilled upstream mammalian cell culture operator in Pune to manage vial revival through large-scale production. The role involves operating single-use bioreactors for seed expansion and production batches, coordinating with cross-functional teams for commercial, validation and PPQ batches.

You will perform in-process sampling, monitor critical parameters, ensure batch compliance, and handle media prep, inoculum development, harvesting, centrifugation and

Qualifications

• Experience in upstream mammalian cell culture from vial revival to production.
• Familiarity with cGMP guidelines and batch compliance.
• Ability to monitor critical process parameters and perform in-process sampling.
• Proficiency in maintaining batch records, logbooks and equipment documentation.

Responsibilities

• Execute upstream mammalian cell culture operations from vial revival to large-scale production.
• Operate and monitor single-use bioreactors for seed expansion and production batches.
• Coordinate with cross-functional teams for commercial, validation and PPQ batches.
• Perform in-process sampling, monitor parameters and ensure batch compliance.
• Handle media preparation, inoculum development, harvesting, centrifugation and reconditioning.
• Troubleshoot bioreactor and process equipment; support deviation management.
• Maintain BPCR, batch records, logbooks and equipment documentation.
• Participate in audit readiness activities including USFDA, EMEA and internal QA inspections.

Skills

Mammalian cell culture

cGMP compliance

Process monitoring

Documentation & records

Tools

Single-use bioreactors

BPCR & batch records

Centrifugation equipment

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.