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Process Technology Senior Scientist
2 months ago
We are seeking a highly skilled Process Technology Senior Scientist to join our team at The Accuro Group. As a key member of our Process Technology department, you will play a critical role in the development and implementation of bioprocessing unit operations.
Key Responsibilities- Participate in process technology transfer from Bioprocess development groups to GMP Operations, including internal and external groups.
- Conduct facility fit assessments, digital data and analytics (DDA) activities, and process introduction activities for bioprocessing unit operations.
- Monitor technical operations of the process through communication with Manufacturing Scientists.
- Represent the Process Technology department at multi-disciplinary matrix teams.
- Present results/conclusions at these meetings.
- Support troubleshooting production problems and the technical success of multi-million-dollar biopharmaceutical production campaigns.
- Ensure that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
- Author campaign summary reports.
- May author, review, and edit batch documentation for cGMP processes.
- Provide training and guidance to Manufacturing Scientists and less experienced personnel.
- B.S. or higher degree in chemical engineering, biochemical sciences, or related engineering/scientific disciplines.
- Familiarity with cGMPs and regulatory requirements.
- Experience with technology transfer and process scale-up.
- 3+ years of experience in upstream cell culture bioprocessing, with a preferred background in chemical, biological, and/or manufacturing sciences.
- Experience in biopharmaceutical process development, technology transfer, scale-up, and cGMP batch execution/troubleshooting is beneficial.
- Knowledge of downstream bioprocessing is a plus.