Sterile Manufacturing - Tech Transfer Project Manager

Sterile Manufacturing - Tech Transfer Project Manager

Responsibilities

• Lead the technical transfer of sterile/parenteral products to external manufacturing partners.
• Assess manufacturing feasibility, identify risks and define critical product and process requirements.
• Prepare and review technical transfer documentation and ensure GMP compliance.
• Analyse transfer data and support deviations, investigations, CAPAs and process improvements.
• Coordinate activities across Manufacturing, Quality, Regulatory Affairs, Supply Chain and external partners.
• Support process validation, manufacturing trials and commercial product introduction.
• Maintain project documentation and support related administrative activities.

Profile

• Several years' experience in sterile pharmaceutical manufacturing, MSAT, process engineering, validation or a similar technical function.
• Strong knowledge of sterile drug-product manufacturing and technology transfer.
• Experience with GMP quality systems, risk assessments, deviations and validation.
• Project management experience and ability to work cross-functionally.
• Knowledge of CMC/regulatory documentation is advantageous.
• Fluent German and English.
• Willingness to travel periodically to other company locations.

If this position seems interesting, please send your CV to sam.brown@discoverinternational.com