Tech Transfer Operations Lead

Flexsis; Basel; Vor Ort; CHF 120.000 - 165.000; Vollzeit

Zusammenfassung

Flexsis, on behalf of Novartis in Basel, is seeking a reliable and motivated Tech Transfer Operations Lead to drive technical transfers for combination products, medical devices, device assembly and secondary packaging from development through commercial manufacturing.

The role requires a Master’s/PhD in a relevant field and at least 5 years of experience in pharmaceutical manufacturing, MS&T, or tech transfer, with strong knowledge of quality systems, regulatory requirements and design control.

Qualifikationen

• University degree (Master or PhD) in Mechanical Engineering, Pharmaceutical Tech, Manufacturing Eng or Packaging Tech.
• 5+ years in pharmaceutical manufacturing, MS&T, technical development, or technical transfer, ideally in device assembly/secondary packaging.
• Strong knowledge of quality systems, regulatory requirements, risk management and applied statistics.
• Practical knowledge of design control and associated documentation (DMR, DHF, pFMEA, Design Verification, URS) and relevant standards.

Aufgaben

• Lead technical transfers from development through commercial manufacturing for combination products and devices.
• Develop and execute transfer strategies with NTO and global cross-functional partners.
• Drive harmonization and standardization of processes and documentation across sites.
• Act as TTL for selected device and secondary packaging transfer and launch projects.
• Lead cross-functional project teams in a global matrix environment with multiple stake holders.
• Bring technical and manufacturing expertise into device development, commercialization, and product lifecycle activities.
• Support design control and development of robust, scalable assembly and packaging processes.

Kenntnisse

Technical transfer leadership

Manufacturing process expertise

Cross-functional leadership

Quality systems knowledge

Regulatory knowledge

Ausbildung

Master's or PhD in Mechanical Engineering

Master's or PhD in Pharmaceutical Technology

Master's or PhD in Manufacturing Engineering

Master's or PhD in Packaging Technology

Jobbeschreibung

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.

For our client Novartis in Basel, we are looking for a reliable and motivated (m/f/d)

Tech Transfer Operations Lead

Duration: 1 year with extension possible

Workload: 80 - 100%

• Lead technical transfers for combination products, medical devices, device assembly, and secondary packaging from development through commercial manufacturing.
• Develop and execute technical transfer strategies in collaboration with NTO and global cross-functional partners.
• Drive harmonization and standardization of manufacturing processes, technical approaches, and documentation across sites.
• Act as Technical Transfer Lead (TTL) for selected device and secondary packaging transfer and launch projects.
• Lead cross-functional project teams in a global matrix environment, partnering with Device Development, Manufacturing, TechOps, Regulatory, Quality, and Supply Chain.
• Bring your technical and manufacturing expertise into device development, commercialization, and product lifecycle management activities.
• Support design control and the development of robust, scalable assembly and packaging processes.

• A university degree, Master's or PhD in Mechanical Engineering, Pharmaceutical Technology, Manufacturing Engineering, Packaging Technology, or a related discipline.
• At least 5 years of relevant experience in pharmaceutical manufacturing, MS&T, technical development, or technical transfer, ideally within device assembly and secondary packaging.
• Solid expertise in combination products, medical devices, assembly, and packaging processes.
• Proven experience in technical transfer, commercialization, manufacturing implementation, and/or product lifecycle management.
• A strong understanding of quality systems, regulatory requirements, risk management, and applied statistics.
• Practical knowledge of design control and associated documentation, including DMR, DHF, pFMEA, Design Verification, and URS.
• Knowledge of relevant regulations and standards, including 21 CFR Parts 210/211, Part 4, Part 820, ISO 13485, ISTA, ASTM, and applicable European medical device requirements.