Director of PET Manufacturing

AstraZeneca GmbH; Hamilton; On-site; CAD 149,000 - 195,000; Full time

Job summary

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining radiopharmaceuticals with PET manufacturing leadership needed to build a robust external network. This role focuses on strategic partnerships, process transfers, and quality oversight to ensure reliable supply for clinical and commercial programs.

The Director will drive cross‑functional collaboration, regulatory readiness, and risk management across geographies, while navigating short half‑life isotope constraints and

Qualifications

• Advanced degree in pharmacy, chemistry, radiochemistry, chemical engineering, pharmaceutical sciences; PhD/PharmD/MS preferred.
• Significant PET radiopharmaceutical manufacturing and external network experience.
• Leadership in multi-site supply operations and external partnerships.

Responsibilities

• Define and implement external PET manufacturing network strategy across geographies.
• Identify, evaluate, and select external manufacturing partners and due diligence.
• Oversee technology transfer, batch documentation, and readiness for clinical supply.
• Establish governance for capacity planning, on-time delivery, and quality metrics.
• Support regulatory inspections readiness and submittals with cross‑functional teams.

Skills

External network leadership

Contract manufacturing relationships

GMP and quality systems

Project and program management

Regulatory submissions support

Cross-functional collaboration

Risk management

Education

PhD/PharmD/MS preferred

Advanced degree in science/engineering

Tools

GMP systems

Job description

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 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 Radioconjugate Manufacture and Development.

Key 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.
• Experience leading technology transfers, site start‑up activities, validation readiness, and operational ramp‑up in external manufacturing environments.
• Proven capability in cross‑functional leadership, stakeholder management, and influencing without direct authority.
• Experience with partner audits, due diligence, quality agreements, and supply governance.
• 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.

Critical Competencies

• Strategic thinking: Ability to translate portfolio requirements into an executable external manufacturing network strategy.
• Technical credibility: Deep understanding of PET manufacturing science and operations, with the ability to challenge and guide external partners effectively.
• Execution focus: Strong bias toward action and delivery in a fast‑paced, time‑sensitive supply environment.
• Risk management: Ability to identify vulnerabilities early and develop practical mitigation strategies.
• Collaboration and influence: Skilled at working across internal and external stakeholders with diverse priorities.
• Decision‑making under constraints: Comfortable making high‑quality decisions in settings with limited capacity, short timelines, and operational complexity.
• Communication: Able to communicate clearly with senior leadership, technical teams, and external partners.

At AstraZeneca, we foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies. You’ll join a collaborative, innovative community with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible. We’re committed to sustainability and equity, taking bold action on climate, access to healthcare, and disease prevention.

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [e-mail].

Annual base salary for this position ranges from 148,645.60 to 195,097.35.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job‑related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity‑based long‑term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.