MSAT USP Expert (m/f/d)
- Lead cross-functional teams for technology transfers, covering the entire project lifecycle
- Act as the interface between process donors and operations, ensuring scalability and manufacturability
- Apply formal processes and tools to manage information transfer, process risks, and change control
- Resolve process issues during manufacturing, adhering to regulatory requirements
- Execute GMP risk analysis for manufacturing processes
- Serve as MSAT process expert in capital investment projects, providing necessary process inputs
- Implement manufacturing processes in the plant
- Nteract with customers during tech transfer, campaign preparation, execution, and closure, including daily batch status reporting
- Compile process-related deviations, change requests, campaign reports, CMC sections in filing documents, and validation reports
- Mentor scientific and production staff, conduct process-specific training, and drive continuous process improvement
- PhD (preferred), Master’s degree in biotechnology, chemical engineering or related disciplines
- Working experience in biopharma manufacturing and / or process development preferable in of Mammalian Manufacturing
- Deep understanding of GMP and bioprocess technology
- Very good communication skills and interaction with all kinds of interfaces within customers and the project organization
- Fluency in English required, German a plus
- Pleasant working atmosphere and flat hierarchies
- Further training opportunities
About the company