Lupin has announced an opportunity for the role of Officer – Production Mammalian at its Pune Biotech location in Maharashtra. This production role is focused on upstream mammalian manufacturing operations, GMP documentation, bioreactor operations, media preparation, cell culture activities and coordination with cross-functional teams.
Job Details
| Company | Lupin |
| Position | Officer – Production Mammalian |
| Department | Production |
| Location | Pune Biotech, MH, IN |
| Work Mode | On-site |
| Experience | 1-4 Years |
Job Description
The selected candidate will be responsible for manufacturing operations related to the upstream area of the Mammalian Manufacturing facility. The role involves GMP documentation, execution of bioreactor and cell culture activities, facility monitoring, production SAP transactions, process validation support and audit readiness as per business requirements.
Key Responsibilities
- Handle manufacturing operations related to the upstream Mammalian Manufacturing facility.
- Prepare and review GMP documents such as SOPs, BPRs, qualification and validation protocols, technology transfer documents and other process or facility related documents for media preparation and cell culture operations.
- Execute disposable bioreactor, SS bioreactor and glass bioreactor operations as per written procedures.
- Execute media fill inoculum transfer and subculture operations as per written procedures.
- Carry out media preparation, CIP and SIP of bioreactors, cell culture and cell banking operations as per written procedures.
- Perform in-process recording of process parameters and in-process sample analysis for media preparation and cell culture operations.
- Maintain facility and equipment related to media preparation, cell culture and cell banking operations.
- Coordinate with QC, QA, Engineering, WH, MSAT and R&D departments.
- Execute qualification activities related to equipment and process.
- Prepare documents related to technology transfer and scale up of process.
- Participate in technology transfer and scale up of process.
- Prepare, execute and maintain SOPs, BPRs, qualification documents and other facility related documents such as URS.
- Handle all production related SAP transactions.
- Plan and execute operations related to process characterization and process validation.
- Review executed BPRs and protocols, logbooks, annexures, checklists and other essential cGMP documents.
- Plan and face internal as well as external audits or visits as per business requirement.
- Assist in deviation identification and investigation for facility related deviations.
- Perform routine monitoring of facility parameters and maintain records such as temperature, humidity and differential pressure.
- Assist in facility validation in coordination with QA.
- Support routine environmental monitoring, record maintenance and coordination with engineering and QC for smooth facility maintenance.
- Manage overall housekeeping activities.
- Comply with current and subsequent EHS management system, procedures, guidelines, policies, practices, requirements and applicable legal compliances on site.
- Carry out any responsibility advised by the superior from time to time.
Qualification
- Graduation in Biotechnology or Life Science.
- Post Graduation in Biotechnology or Life Science.
Experience
- 1-4 years of work experience is required.
How to Apply
Interested candidates can apply online through the official Lupin careers link given below.
