Director of PET Manufacturing

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radio conjugates that deliver powerful alpha‑emitting payloads directly to tumors. Our pipeline spans multiple first‑in‑class programs—backed by a GMP‑compliant, state‑of‑the‑art radiopharmaceutical facility in Hamilton, we’re turning cutting‑edge science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us!

Note:
This role is 5 days per week onsite.

The Director of PET Manufacturing, External Network is responsible for developing and leading a robust external manufacturing network for positron emission tomography (PET) radiopharmaceuticals. The role focuses on building strategic partnerships with contract manufacturing organizations, hospital-based radio pharmacies, academic production sites, and commercial PET manufacturing providers to ensure reliable, compliant, and scalable supply. This leader will define and execute the external manufacturing strategy, oversee network performance, and work cross-functionally to support clinical and commercial objectives across the PET portfolio.

The position requires deep expertise in PET radiopharmaceutical manufacturing
, external supply models,
GMP
, quality oversight, technology transfer, and distribution constraints associated with short half‑life isotopes. The individual will operate at the interface of technical operations, quality, regulatory, supply chain, and business development to establish a high-performing external network capable of meeting evolving pipeline and market needs. This role reports into the Head of Radio conjugate Manufacture and Development.

• External network strategy
  :
  Define and implement the strategy for building an external PET manufacturing network across target geographies, aligned to portfolio demand, development milestones, and commercialization plans.
• Partner identification and selection
  :
  Identify, assess, and prioritize potential external PET manufacturing partners, including CDMOs, nuclear pharmacies, academic centers, and regional radiopharmaceutical producers.
• Due diligence and capability assessment
  :
  Lead technical, operational, quality, and business due diligence for prospective partners, evaluating cyclotron access, synthesis capability, aseptic processing, QC release, qualified personnel, capacity, distribution reach, and compliance maturity.
• Network design
  :
  Develop the footprint model for external PET production, taking into account isotope half‑life, patient scheduling, dose delivery windows, geographic coverage, redundancy needs, and business continuity requirements.
• Contracting support
  :
  Partner with procurement, legal, finance, and business development teams to support commercial negotiations, quality agreements, supply agreements, statements of work, and performance frameworks.
• Technology transfer and launch readiness
  :
  Oversee transfer of manufacturing processes, analytical methods, batch documentation, and operational practices into external sites, ensuring readiness for clinical supply and commercial launch.
• Operational oversight
  :
  Establish governance and performance management processes for external manufacturing partners, including capacity planning, production reliability, right‑first‑time performance, deviation trends, change control, and on‑time dose delivery.
• Supply continuity and risk management
  :
  Build contingency plans and network resilience strategies to address cyclotron downtime, raw material shortages, site outages, transportation disruptions, and other risks inherent to PET manufacturing and distribution.
• Cross‑functional collaboration
  :
  Serve as the primary operations lead across technical operations, quality assurance, regulatory affairs, clinical supply, commercial, medical, and program leadership for matters related to the external PET network.
• Regulatory inspection readiness
  :
  Support partner readiness for regulatory inspections and internal audits, and ensure timely remediation of observations, CAPAs, and compliance…