Mammalian Production Executive

Executive - GMP

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 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.

Work Experience

3 to 6 years

Education

Graduation in Biotechnology or BiotechnologyPost Graduation in Biotechnology or Biotechnology

Competencies

5. Result Orientation6. Process Excellence7. Collaboration

Experience Level

Executive Level