Officer, Production Mammalian

About the Role

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

Key Responsibilities

• 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.
• 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-ordination 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.
• Responsible for all production-related SAP transaction.
• Plan and execute operations related to process characterization & process validation.
• Review of executed BPRs and protocols, logbooks, annexures, checklists, 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 facility-related deviations.
• Routine monitoring of facility and record maintenance (e.g., temperature, humidity, differential pressure).
• 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.
• Any responsibility advised by the superior from time to time.
• Compliance with current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.

Qualifications

• Masters in Biotechnology, Others in Life Science, or Pharmacy.
• Work Experience: 0-2 years.