AstraZeneca

AstraZeneca

Director of PET Manufacturing

Canada – Hamilton – Longwood Road South · Director · Contract

Sponsorship not specified$149k-$195kDetected 4 days ago
Stakeholder ManagementBusiness DevelopmentBudgetingSupply ChainProcurementPerformance ManagementGMPFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs

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64Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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About the role

  • 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.
  • Note: This role is 5 days per week onsite.
  • 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.

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.
  • 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.
  • 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.
  • 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.
  • Demonstrated leadership experience in building or managing external manufacturing networks, contract manufacturing relationships, or multi-site supply operations.
  • Strong business acumen, including budgeting, contract support, network planning, and risk-based decision-making.

Requirements

  • Significant experience in PET radiopharmaceutical manufacturing, radiopharmacy operations, or nuclear medicine manufacturing within clinical and/or commercial settings.
  • Strong knowledge of PET manufacturing workflows, including radionuclide production, synthesis, aseptic filling, environmental controls, release testing, and time-critical distribution.
  • 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.
  • Willingness to travel as required to evaluate and support external manufacturing sites.
  • Strategic thinking: Ability to translate portfolio requirements into an executable external manufacturing network strategy.

Nice to have

  • Advanced degree in pharmacy, chemistry, radiochemistry, chemical engineering, pharmaceutical sciences, or a related scientific/technical discipline.
  • A PhD, PharmD, or MS is preferred.

Compensation

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

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.
  • Strong understanding of GMP, quality systems, regulatory submissions support, and health authority expectations relevant to radiopharmaceuticals.

Company info

  • At AstraZeneca, we foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies.
  • We are using AI as part of the recruitment process.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.