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.

Qualification

• 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.