Senior Engineer- Plasmid (MS&T)
Reporting to the Director of External MS&T, the Senior Engineer, MS&T will be part of the Manufacturing Science and Technology team responsible for ensuring the robust technology transfer and technical support of our plasmid production platform. The individual will work closely within MS&T, and with Process Development, Manufacturing, Regulatory, and Quality, to lead technology transfer and cGMP manufacturing support for plasmid manufacturing.
Here’s What You’ll Do:
- Support technology transfer projects including coordination of process information exchange, documentation of technology transfer and tracking process performance.
- Lead cGMP technical activities including change management, manufacturing deviation investigation, and continual improvement. Collaborate with process development on studies to determine root cause for deviations.
- Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories.
- Author and execute protocols supporting process characterization and equipment scale up in manufacturing.
Here’s What You’ll Bring to the Table:
- Biochemical engineer, Chemical engineer, or Biochemistry Professional with a BS and 10+ years of experience, or MS and 5+ years in a pharmaceutical or biotechnology company.
- Prior experience in plasmid process development or manufacturing.
- Subject matter expertise in bioprocessing unit operations which may include: fermentation, clarification, chromatography, and tangential flow filtration.
- Experience in biologics process development or cGMP manufacturing of biologic products.
- Excellent judgment and ability to communicate manufacturing issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.