Technology Transfer Lead - Sterile GMP Drug Product

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Dynamic work culture

Competitive compensation

Zusammenfassung

Lonza in Stein, Switzerland, is seeking a Technology Transfer Lead to oversee sterile GMP drug product transfers from clinical development through first commercial launch. You will define project scope, timelines, risks, and milestones, lead process setup and scale-up at GMP sites, and maintain transfer documentation.

You will collaborate with cross-functional teams and support regulatory docs and inspections, communicating effectively in English.

Qualifikationen

• Ph.D. or Master in pharmaceutical sciences, pharmaceutical engineering, chemistry, biochemistry, or related fields or similar qualification.
• Significant experience in biotech/pharma industry.
• Knowledge of drug product technical transfers.
• Aseptic product manufacture for protein drug products incl. lyophilization; ADCs knowledge desirable.
• Strong leadership and cross-functional team management.
• Excellent planning, organizing and risk management skills.
• Excellent English communication (written and spoken).

Aufgaben

• Lead technical transfer activities for sterile GMP drug product manufacturing projects.
• Manage drug product transfers from clinical development through first commercial launch.
• Define project scope, timelines, risks, and milestones, and track progress.
• Lead process setup, scale-up, and implementation at GMP manufacturing sites.
• Prepare and maintain technical transfer and process documentation.
• Drive GMP change management and handle deviations and CAPAs.
• Support regulatory documentation, inspections, audits, and customer interactions.

Kenntnisse

Technical transfer

GMP

Aseptic manufacturing

Project management

Cross-functional leadership

English proficiency

Ausbildung

PhD or MSc in pharmaceutical sciences/related field

Jobbeschreibung

Lonza in Stein, Switzerland, is seeking a Technology Transfer Lead to oversee sterile GMP drug product transfers from clinical development through first commercial launch. You will define project scope, timelines, risks, and milestones, lead process setup and scale-up at GMP sites, and maintain transfer documentation.

You will collaborate with cross-functional teams and support regulatory docs and inspections, communicating effectively in English.