Senior Executive – Production Mammalian

Lupin; Pune District; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Lupin is seeking a skilled professional for upstream mammalian manufacturing operations within our Mammalian Manufacturing facility in India. You will be responsible for preparing and reviewing GMP documents for media preparation and cell culture processes, and for executing bioreactor operations as per SOPs.

You will also perform media fills, inoculum transfers, and subcultures, while ensuring CIP/SIP of equipment, maintaining facilities, and coordinating with QC, QA, Engineering, WH, MSAT and

Qualifications

• 7-8 years of experience in upstream mammalian manufacturing.
• Post Graduation required; Graduation in Biotechnology or Life Science.
• Strong knowledge of GMP documentation and tech transfer processes.

Responsibilities

• Prepare and review GMP documents like SOPs, BPRs, qualification and validation protocols, technology transfer docs for media preparation and cell culture operations.
• Execute disposable bioreactor, SS bioreactor and glass bioreactor operations per SOP.
• Perform media fill, inoculum transfer and subculture as per procedures.
• Carry out CIP/SIP of bioreactors, cell culture and cell banking as per procedures.
• Record in-process parameters and perform in-process sample analysis.
• Maintain facility and equipment related to media prep, cell culture and cell banking operations.
• Coordinate with QC, QA, Engineering, WH, MSAT and R&D departments.

Education

Post Graduation

Graduation in Biotechnology or Life Science

Job description

Responsible for manufacturing operations related to upstream of Mammalian Manufacturing facility.

• Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, technology transfer documents and other process or facility related documents for media preparation and cell culture operations.
• Execution of disposable bioreactor, SS bioreactor and glass bioreactor operations as per written procedure.
• Execution of media fill, inoculum transfer and subculture operations as per written procedure.
• Responsible for execution of media preparation, CIP and SIP of bioreactors, cell culture and cell banking operations as per written procedures.
• In-process recording of process parameters and In-process sample analysis for media preparation and cell culture operations.
• Maintenance of facility and equipment related to media preparation operations, cell culture operations and cell banking operations.
• Co-ordinate with QC, QA, Engineering, WH, MSAT and R & D departments.
• Execution of qualification activities related to equipment and process.
• Preparation of documents related to tech transfer and scale up of process. Participate in tech transfer and scale up of process.
• Preparation, execution & maintenance of SOPs, BPRs, qualification documents and other facility related documents i.e. URS.
• Plan and execute operations related to process characterization & process validation.
• Review of executed BPRs and protocols.
• Planning and facing of internal as well as external audits/visits as per business requirement.
• Deviation identification and investigation assistance for the facility related deviations.

Work Experience

7-8 years

Education

Post Graduation

Graduation in Biotechnology or Life Science