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”Search, find and apply to our job opportunities at Boston Institute of Biotechnology. Bring your insight, imagination and healthy disregard for the impossible.Peng JiaoCEO, Boston Institute of Biotechnology
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.