Sterile Manufacturing - Tech Transfer Project Manager

Discover International; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Discover International seeks a Tech Transfer Project Manager for sterile manufacturing to lead cross-site transfers of sterile/parenteral products to external partners.

You will assess feasibility, define critical product and process requirements, review GMP-compliant transfer docs, and drive risk assessments, CAPAs and process improvements across Manufacturing, Quality, Regulatory Affairs and Supply Chain.

Qualifikationen

• Several years of experience in sterile pharmaceutical manufacturing, MSAT, process engineering or similar.
• 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 advantageous.
• Fluent German and English.
• Willingness to travel periodically to other company locations.

Aufgaben

• 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.

Kenntnisse

Sterile pharmaceutical manufacturing

MSAT

Process engineering

Validation

Project management

GMP/compliance

German-English fluent

Jobbeschreibung

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.