Sterile Manufacturing - Tech Transfer Project Manager
Discover International ·
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