Responsable production/ Responsable fabrication H/F
AstraZeneca
Fusion Pharmaceuticals (AstraZeneca) seeks a Director to build and manage an external manufacturing network for PET radiopharmaceuticals across multiple geographies. The role combines technical expertise in radiopharmaceutical operations with strategic partnership development, quality oversight, and cross-functional leadership to support clinical and commercial objectives.
Define and implement external PET manufacturing network strategy aligned to portfolio demand and commercialization timelines
Identify, assess, and select contract manufacturing organizations, nuclear pharmacies, and academic production partners
Lead technical and quality due diligence evaluating cyclotron access, synthesis capability, compliance maturity, and capacity
Oversee process technology transfer and launch readiness to external manufacturing sites
Establish governance and performance management frameworks for external partners including capacity planning and risk mitigation
Advanced degree (PhD, PharmD, or MS preferred) in pharmacy, chemistry, radiochemistry, or pharmaceutical sciences
Significant experience in PET radiopharmaceutical manufacturing or radiopharmacy operations in clinical/commercial settings
Demonstrated leadership building or managing external manufacturing networks and multi-site supply operations
Strong knowledge of PET manufacturing workflows including radionuclide production, synthesis, aseptic filling, and distribution
Deep understanding of GMP, quality systems, and regulatory requirements for radiopharmaceuticals
Experience leading technology transfers, site start-ups, and validation in external manufacturing environments
Proven cross-functional leadership and stakeholder management capability with willingness to travel
Vacancy posted 22 days ago
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