Together We Build Dreams
About the job
As a MSAT Engineer/Scientist, you are responsible for internal/external technology transfers and manufacturing support covering Upstream (USP), Downstream (DSP) and Fill&Finish (F&F) process. As a Subject Matter Expert of MSAT, you will provide advice and guidance on manufacturing technology issues, initiatives and strategy for continuously improving manufacturing performance.
Duty and Responsibility
- Perform product technology transfer such as Mammalian Cell Culture, Microbial Fermentation and Purification processes from the Process Development team and/or external customer site to GMP Manufacturing.
- Perform Risk Assessment & Mitigation during product technology transfer and manufacturing.
- Support equipment PQ, Deviation Investigation, CAPA and Change Control.
- Develop and review Manufacturing Process Description, Master Production Records and Process Performance Qualification/Process Validation Protocols.
- Write and review GMP production reports and related documents to support CMC requirements.
- Degree BS, MS or Ph.D.
- Major Chemical Engineering, Biochemical Engineering, Biotechnology or equivalent with 3+ year relevant experience in biologic process or commercial biologic manufacturing.
- Experience Minimum of 3+ year experience in biologic process or commercial biologic manufacturing.
- Skills Knowledge of biologic GMP manufacturing equipment and process. Skillful in trouble shooting, technical writing and communication.