Biotech Senior Executive Production Mammalian MH

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. · Responsible for all Production related SAP Transaction.

Work Experience

8-10 years

Education

Post Graduation in Biotechnology or Life Science

Graduation in Biotechnology or Life Science

Competencies