Executive - Production Mammalian

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 SOPs, BPRs, qualification documents and other facility related documents i.e. URS.
•    Plan and execute operations related to process characterization & process validation.
•    Review of executed BPRs and protocols. Exexusion of PAS-X BMR

Work Experience

3-8 years 

Education

Competencies