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AstraZeneca

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Director of PET Manufacturing

🗓️ Posted 2026-09-03 Canada – Hamilton – Longwood Road South Full-time Hybrid Manufacturing Transport Logistics

Company shared salary

NA

Market rate

12,500 CAD–18,000 CAD/mo (150,000 CAD–216,000 CAD/yr)

Based on similar roles (title + domain + location).

About the Company

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next generation radioconjugates 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. Role Summary 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 radiopharmacies, 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

Responsibilities

  • ● 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 gaps.
  • ● Continuous improvement : Drive standardization, operational excellence, and process improvements across the external network to improve throughput, compliance, cost, and service levels.
  • ● Required Qualifications
  • ● Advanced degree in pharmacy, chemistry, radiochemistry, chemical engineering, pharmaceutical sciences , or a related scientific/technical discipline. A PhD, PharmD, or MS is preferred.
  • ● Significant experience in PET radiopharmaceutical manufacturing , radiopharmacy operations, or nuclear medicine manufacturing within clinical and/or commercial settings.
  • ● Demonstrated leadership experience in building or managing external manufacturing networks , contract manufacturing relationships, or multi-site supply operations.
  • ● Strong knowledge of PET manufacturing workflows , including radionuclide production, synthesis, aseptic filling, environmental controls, release testing, and time-critical distribution.
  • ● Strong understanding of GMP , quality systems, regulatory submissions support, and health authority expectations relevant to radiopharmaceuticals.
  • ● Proven capability in cross-functional leadership, stakeholder management, and influencing without direct authority.
  • ● Strong business acumen, including budgeting, contract support, network planning, and risk-based decision-making.
  • ● Willingness to travel as required to evaluate and support external manufacturing sites.