Manufacturing Technology Transfer Expert (m/f/d), France

By bridging the gap between the physical and digital worlds, we help to accelerate digitalisation and sustainability: so that our customers around the world can become more competitive, resilient and sustainable.

Tasks

• Lead end‑to‑end Technology Transfer projects, managing timelines, deliverables, and cross‑functional coordination: MS&T, Quality, TRD (Research & Development), Engineering, IT, suppliers, and external partners.
• Define qualification and validation strategies for new QC/production processes and equipment across Radiopharma network, in alignment with MS&T, Global Tech Ops, and Quality.
• Oversee the preparation and execution of qualification documentation (IQ/OQ/PQ) and ensure proper installation and validation activities.
• Drive technology scouting with Engineering to identify, source, and test new solutions that enhance process efficiency while meeting Safety, GMP, and Annex 1 requirements.
• Ensure strong collaboration and stakeholder alignment throughout the project lifecycle — from initiation and planning to execution and close‑out.
• Support and contribute to training activities for new equipment, methods, and processes.
• Ensure site readiness post‑transfer, covering equipment, methods, and processes.
• Participate in local/global change control and implementation of action plans.
• Contribute to SOP development for manufacturing and QC operations.
• Harmonize and distribute qualification documentation across PET manufacturing sites.
• Act as a Subject Matter Expert (SME) during GMP inspections and serve as a key point of contact for your scope.
• This role requires occasional travel across Europe, approximately one week per month.

Profile

• Bachelor’s or Master’s degree in Chemistry, Pharmacy, or any related field.
• Minimum 3 years experience in pharmaceutical production or quality control within highly regulated environments.
• Solid understanding of sterile process design and strong familiarity with EU GMP requirements — particularly Annex 1.
• Ability to understand and navigate complex technical activities, processes, and equipment.
• Excellent written and spoken English, with strong interpersonal skills that enable effective collaboration across diverse teams and stakeholders.