Associate Director, CMC Program Management

AstraZeneca • Santa Monica, CA

8d

About The Position

The Associate Director, Cell Therapy CMC Project Manager is part of the CMC Project Management – Portfolio Strategy team within Cell Therapy Technical Operations. The role partners with the CMC Program Leader, who owns product-level CMC strategy and outcomes, to translate cell therapy drug-product and CMC development strategy into integrated, executable plans from early development through clinical development and launch.

The position is accountable for the integrity and visibility of the overall CMC project plan as the program’s single source of truth, covering scope, milestones, timelines, dependencies, risks, resources, and budget. It establishes and operates the governance cadence, decision processes, and follow-through needed to support disciplined delivery, anticipate risks, and align process development, analytical development, manufacturing, quality, supply chain, regulatory interfaces, and external partners.

The Associate Director also supports CMC portfolio strategy and the CMC operating model by advancing standardized ways of working, portfolio visibility, project-management capabilities, and the use of digital and AI-enabled project-management tools.

Requirements

• Bachelor’s, master’s, or PhD in a relevant scientific, engineering, or technical discipline, or equivalent relevant industry experience.
• Relevant experience: 10+ years with a BS, 5+ years with an MS, or 3+ years with a PhD.
• Demonstrated experience in CMC, technical development, process development, manufacturing, or CMC project/program management within the biopharmaceutical industry.
• Demonstrated ability to lead complex cross-functional CMC projects, translating technical strategy into actionable integrated execution plans in partnership with a CMC Program Leader.
• Strong understanding of CMC drug-product development and interdependencies among process development, analytical development, manufacturing, quality, regulatory activities, and supply chain.
• Advanced project-management capability across integrated scheduling, critical-path analysis, dependency management, risk management, scenario planning, resource planning, and financial management.
• Ability to identify emerging risks, constructively challenge assumptions, facilitate timely decisions, escalate early, and drive actions through resolution.
• Strong capability with Microsoft Project, Smartsheet, and/or comparable enterprise project- and portfolio-management tools.
• Proficiency and willingness to adopt AI-enabled project-management, automation, and productivity tools.
• Strong communication and facilitation skills, including the ability to translate complex CMC information into concise, decision-oriented insights for project teams and senior leaders.
• Demonstrated ability to influence and align cross-functional stakeholders without direct authority.
• Ability to operate independently in a dynamic environment while maintaining strong partnerships with CMC Program Leaders and functional teams.
• Strong focus on standardization, continuous improvement, simplification, and scalable ways of working.

Nice To Haves

• Knowledge of cell therapy CMC development, preferably including autologous, allogeneic, or in vivo approaches.
• Understanding of drug-product/process development, analytical development, clinical manufacturing, technology transfer, quality, regulatory expectations, and/or supply chain within a CMC environment.
• Project-management training or professional certification such as PMP.

Responsibilities

• Translate cell therapy drug-product and CMC development strategies into phase-appropriate integrated plans covering development, clinical manufacturing, regulatory deliverables, technology transfer, manufacturing network activities, and commercialization readiness.
• Develop and maintain multi-year CMC integrated plans that include milestones, critical path, dependencies, resources, budget, risks, and key decision points.
• Connect process development, analytical development, manufacturing, quality, supply chain, and regulatory activities into one executable CMC plan in partnership with CMC Program Leaders and functional experts.
• Maintain project-plan integrity as program assumptions, technical strategy, priorities, and development timelines change.
• Manage program changes through a consistent change-control process linked to development milestones and lifecycle management, and track jurisdictional and regulatory-approval dependencies affecting CMC plans.
• Drive execution against governance-endorsed scope, timelines, milestones, resources, and budget; maintain the project plan as the single source of truth and ensure decisions and actions are followed through.
• Identify cross-functional dependencies, risks, issues, and schedule impacts; work with accountable owners on mitigation and contingency plans and escalate when required.
• Lead CMC project-team operating rhythms, including agendas, decisions, actions, and follow-up, with an emphasis on decision-making and execution.
• Support the CMC Program Leader in routing decisions to the appropriate forum with clear inform, endorse, or decide guidance; prepare decision-ready materials 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 to address complex project challenges when required.
• Support pre-alignment of program communications across Program Steering Committee, functional heads, and enterprise forums; escalate early and avoid unaligned external commitments.
• Partner with CMC Program Leaders, Global Program Managers, Finance partners, and functional leaders on resource forecasting, external budget planning, allocation, maintenance, and reconciliation.
• Support assumption-based resource-demand submissions and review forecast versus actuals to improve resource-planning realism.
• Provide program-level information for portfolio prioritization, resource decisions, scenario planning, and trade-off discussions; maintain visibility across schedules, milestones, risks, resources, and financials.
• Assess potential CMC impacts when program priorities, technical assumptions, timelines, or resource constraints change.
• Champion consistent, phase-appropriate CMC project-management standards, tools, and ways of working across programs and functional sub-teams.
• Establish and maintain fit-for-purpose tools for planning, scheduling, RAID management, financial tracking, portfolio reporting, and decision support.
• Apply Microsoft Project, Smartsheet, PLANIT, and related portfolio/project-management platforms to improve planning discipline, data quality, and transparency.
• Use AI-enabled project-management and productivity tools to improve planning, synthesis, reporting, risk identification, and project-management efficiency.
• Identify and implement practical process, tool, automation, and AI improvements that simplify ways of working and strengthen project and portfolio visibility.
• Contribute to continuous improvement and evolution of the CMC Project Management operating model.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in the equity-based long-term incentive program for salaried roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior