On-Site Tech Transfer Lead – Sterile GMP Manufacturing

Lonza Group Ltd.; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Lonza Group Ltd. in Visp, Switzerland is seeking a seasoned professional to lead technical transfer activities for sterile GMP DP manufacturing and to manage drug product transfers from development to first commercial launch.

You will define scope, timing and progress while ensuring strict adherence to quality and regulatory standards. The role requires an advanced degree in pharmaceutical sciences or related field, extensive biotech experience, and strong communication and project-management

Qualifikationen

• PhD or Bachelor/Master in pharmaceutical sciences or related field.
• Extensive biotech/pharma industry experience.
• Knowledge of drug product technical transfers.
• Aseptic manufacture for protein drugs; lyophilization and prefilled syringes assets.
• Excellent communication and teamwork abilities.
• Strong planning, risk management and technical writing.

Aufgaben

• Lead technical transfer activities for sterile GMP DP manufacturing.
• Manage technical activities for drug product transfers from development to first commercial launch.
• Define and monitor project scope, timing and progress.
• Lead setup, scale-up and implementation of manufacturing processes at GMP DP sites and provide on-site support.
• Responsible for process implementation and technical transfer documentation.
• Drive GMP change management and change control in systems.
• Lead and support deviations and CAPAs.
• Ensure activities comply with cGMP, HSE and regulatory standards.
• Enable innovation and evaluate new methods/technologies; contribute IP/publications.

Kenntnisse

Pharmaceutical sciences

Pharmaceutical engineering

Chemistry

Biochemistry

Communication skills

Project management

Ausbildung

PhD or Master/Bachelor in relevant field

Jobbeschreibung

Lonza Group Ltd. in Visp, Switzerland is seeking a seasoned professional to lead technical transfer activities for sterile GMP DP manufacturing and to manage drug product transfers from development to first commercial launch.

You will define scope, timing and progress while ensuring strict adherence to quality and regulatory standards. The role requires an advanced degree in pharmaceutical sciences or related field, extensive biotech experience, and strong communication and project-management