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AstraZeneca

Associate Director, CMC Program Management

Location
US – Santa Monica Colorado Avenue – CA (Multi-state)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Corporate/Other
Industry
Pharma/Biotech
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From the employer's posting

Do you have a passion for science and an interest in translating innovative science into medicines that can make a meaningful difference for patients?

At AstraZeneca, we put patients first and follow the science to deliver life-changing medicines. We foster an inclusive, collaborative environment where people are encouraged to think strategically, act with urgency, challenge convention, and work across boundaries to turn ambitious ideas into meaningful outcomes.

Summary of the Position

The Associate Director, Cell Therapy CMC Project Manager is a member of the CMC Project Management – Portfolio Strategy team within Cell Therapy Technical Operations.

The CMC Project Manager acts as the strategic execution partner to the CMC Program Leader, who owns product-level CMC strategy and outcomes. Working with the Program Leader and cross-functional technical teams, the CMC Project Manager translates cell therapy drug-product and CMC development strategy into the how and when: integrated, executable plans from early development through clinical development and launch.

The role is accountable for the integrity and visibility of the overall CMC project plan, which serves as the program's single source of truth, including scope, milestones, timelines, dependencies, risks, resources, and budget. The CMC PM creates and runs the management system (governance cadence, decisions, and follow-through) that converts strategy into disciplined delivery, anticipates risks before they affect delivery, and drives cross-functional alignment across process development, analytical development, manufacturing, quality, supply chain, regulatory interfaces, and external partners to enable predictable CMC delivery.

The Associate Director also contributes to CMC portfolio strategy and the CMC operating model, strengthening standardized ways of working, portfolio visibility, project-management capabilities, and adoption of digital and AI-enabled PM tools.

Main Duties & Responsibilities

CMC Development & Integrated Project Planning

  • Translate cell therapy drug-product and CMC development strategies into integrated, phase-appropriate project plans covering development, clinical manufacturing, regulatory deliverables, technology transfer, manufacturing network activities, and commercialization readiness.
  • Develop and maintain multi-year CMC integrated plans, including milestones, critical path, dependencies, resources, budget, risks, and key decision points.
  • Partner with CMC Program Leaders and functional experts to connect process development, analytical development, manufacturing, quality, supply chain, and regulatory activities into a single executable CMC plan.
  • Maintain plan integrity as program assumptions, technical strategy, priorities, or development timelines evolve.
  • Manage program changes through a consistent change-control process linked to development milestones and lifecycle management, and track jurisdictional and regulatory-approval dependencies that affect CMC plans.

Project Execution, Risk & Governance

  • Drive execution against governance-endorsed scope, timelines, milestones, resources, and budget; maintain the project plan as the single source of truth and ensure follow-through on decisions and actions, with transparent visibility of project status and performance.
  • Proactively identify cross-functional dependencies, risks, issues, and schedule impacts; partner with accountable owners to define mitigation and contingency plans and escalate when required.
  • Lead effective CMC project-team operating rhythms, including agendas, decisions, actions and follow-up, with a focus on decision-making and execution rather than administration.
  • Support the CMC Program Leader in routing each decision to the appropriate forum (function, CMC team, Program Steering Committee, or senior leadership) with clear inform, endorse, or decide guidance, using decision-ready formats (context, options, recommendation, and ask), and maintain a decision log with owners and follow-up.
  • Prepare clear, decision-focused project updates and integrated CMC information for governance and senior leadership discussions.
  • Facilitate cross-functional planning and problem-solving workshops when required to resolve complex project challenges.
  • Support the CMC Program Leader in pre-aligning program communications across the Program Steering Committee, functional heads, and enterprise forums so that CTTO presents one integrated position; escalate early and avoid unaligned commitments to external parties.

Portfolio Strategy, Resources & Financial Management

  • Partner with CMC Program Leaders, Global Program Managers, Finance partners, and functional leaders to support resource forecasting, external budget planning, allocation, maintenance, and reconciliation, including assumption-based resource demand submissions and review of forecast versus actuals to improve the realism of resource planning.

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