MSAT USP Expert (m/f/d)

Ihre Aufgaben:
• 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

Ihre Qualifikationen:
• 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

Ihre Vorteile:
• Pleasant working atmosphere and flat hierarchies
• Further training opportunities

Projektdauer: 12 MM


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