Officer - Production Mammalian

Lupin; Pune District; Vor Ort; INR 420.000 - 600.000; Vollzeit

Zusammenfassung

Lupin in Pune seeks a biotech manufacturing operations professional focused on upstream mammalian culture. You will oversee media preparation, cell culture, bioreactor operations and GMP documentation while coordinating with QA/QC, engineering and R&D teams.

The role requires a 0–2 year background with a Masters in Biotechnology or a related field. Hands-on exposure to media prep, culture processes and tech transfer is preferred.

Qualifikationen

• Masters in Biotechnology or related field.
• 0–2 years of relevant experience.
• Experience with media preparation, cell culture and GMP documents.

Aufgaben

• Responsible for upstream mammalian manufacturing operations.
• Prepare and review GMP documents (SOPs, BPRs, protocols) and tech transfer papers.
• Execute disposable bioreactors, SS and glass bioreactors per procedure.
• Perform media fill inoculum transfer and subculture activities as per SOPs.
• Carry out media preparation, CIP/SIP of bioreactors and cell culture operations.
• In-process parameter recording and sample analysis for media prep and culture.
• Maintain facility and equipment related to media prep, culture and cell banking.
• Coordinate with QC, QA, Engineering, WH, MSAT and R&D.
• Participate in qualification activities for equipment and processes.
• Support tech transfer and scale-up activities.
• Prepare, execute and maintain SOPs, BPRs, qualification docs and URS.
• Handle SAP production transactions and process validations.
• Assist in facility validation with QA and audits.
• Monitor environmental conditions and assist facilities team.

Kenntnisse

Mammalian upstream ops

Ausbildung

Master's in Biotechnology

Life Science or Pharmacy background (Masters)

Tools

SAP

Jobbeschreibung

• 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 bioreactors and glass bioreactors 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 SOP’s, BPRs, qualification documents and other facility related documents i.e. URS.
• Responsible for all production related SAP transaction.
• Plan and execute operations related to process characterization & process validation.
• Review of executed BPR’s and protocols, logbooks, annexures, checklist and other essential cGMP documents.
• 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
• Routine monitoring of facility and record maintenance e.g. temperature, humidity, differential pressure. To assist in facility validation in coordination with QA.
• Routine environmental monitoring, record maintenance and co-ordination with engineering and QC department for smooth facility maintenance.
• Overall housekeeping management.
• To assist in facility validation in coordination with QA.
• Any responsibility advised by the superior from time to time.
• To comply with the current & subsequent EHS management system, procedures, guideline, policy, practices, requirement and applicable legal compliances on site.

Work Experience

0-2 year

Education

Masters in Biotechnology

Others in Life Science or Pharmacy

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