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Process Technology Senior Scientist

2 months ago


King of Prussia, Pennsylvania, United States The Accuro Group Full time
Job Summary

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.
Requirements
  • 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.