About this role
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 SOP’s, BPRs, qualification documents and other facility related documents i.e. URS.
- Plan and execute operations related to process characterization & process validation.
- Review of executed BPR’s 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.
- To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.
Work Experience 1 to 4 years Education Masters in Biotechnology Graduation in Microbiology Competencies Building a Safe Environment Shared Goals