Tech Transfer Lead: Medical Devices & Packaging

CTC Resourcing Solutions; Basel; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Zusammenfassung

The Tech Transfer Operations Lead (TTO) role is based in Basel and focuses on technical transfer operations for combination products, medical devices and secondary packaging within the GDPD network. You will harmonize cross-site transfers from development to site level and support device assembly and packaging launches. We seek a PhD or Dipl.

Ing. in Mechanical Engineering or Pharmaceutical Technology with at least 5 years in pharma manufacturing, strong regulatory knowledge, and proven ability

Qualifikationen

• PhD or Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology.
• Minimum 5 years of professional experience in pharmaceutical manufacturing / packaging.
• Strong understanding of regulatory requirements and quality systems across health authorities.
• Knowledge of design control, documentation, risk management and related processes.

Aufgaben

• Technical transfer operations for combination products, medical devices and secondary packaging.
• Provide expertise for strategy, process, technical and systems topics during development and commercialization.
• Establish and execute transfer strategy and harmonize cross-site manufacturing transfers.
• Coordinate development support of product maintenance and manage teams to implement changes.
• Lead or deputize transfer and launch activities for device assembly and packaging across sites.
• Support audits on packaging and medical devices; contribute to registrations and health authority responses.
• Prepare function-related documents for regulatory submissions and product registrations.

Kenntnisse

Technical transfer operations

Pharmaceutical manufacturing

Design control

Quality systems

Regulatory requirements

Cross-functional collaboration

Project management

Statistical methods

Documentation writing

Device Master Record (DMR)

Ausbildung

PhD or Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology

Jobbeschreibung

The Tech Transfer Operations Lead (TTO) role is based in Basel and focuses on technical transfer operations for combination products, medical devices and secondary packaging within the GDPD network. You will harmonize cross-site transfers from development to site level and support device assembly and packaging launches. We seek a PhD or Dipl.

Ing. in Mechanical Engineering or Pharmaceutical Technology with at least 5 years in pharma manufacturing, strong regulatory knowledge, and proven ability