Associate Director, CMC Program Management

AstraZeneca • Santa Monica, CA

1d • $136,514 - $204,771

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 acts as the strategic execution partner to the CMC Program Leader, who owns product-level CMC strategy and outcomes. In partnership with the Program Leader and cross-functional technical teams, the CMC Project Manager turns 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, the program’s single source of truth for scope, milestones, timelines, dependencies, risks, resources, and budget. The Associate Director establishes and runs the management system—including governance cadence, decisions, and follow-through—to convert strategy into disciplined delivery, anticipate risks, and align process development, analytical development, manufacturing, quality, supply chain, regulatory interfaces, and external partners.

The role also contributes to CMC portfolio strategy and the CMC operating model by strengthening standardized ways of working, portfolio visibility, project-management capabilities, and adoption 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 of 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.
• Knowledge of cell therapy CMC development.
• Understanding of drug-product and process development, analytical development, clinical manufacturing, technology transfer, quality, regulatory expectations, and/or supply chain in a CMC environment.
• Ability to lead complex, cross-functional CMC projects as an execution leader, translating technical strategy into actionable integrated plans in partnership with the 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, challenge assumptions constructively, facilitate timely decisions, escalate early, drive actions through resolution, and take ownership of overall program health.
• 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 clear, concise, decision-oriented insights for teams and senior leaders.
• Ability to influence and align cross-functional stakeholders without direct authority.
• Ability to work 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.
• Project-management training or professional certification such as PMP.

Responsibilities

• Translate cell therapy drug-product and CMC development strategies into integrated, phase-appropriate plans covering development, clinical manufacturing, regulatory deliverables, technology transfer, manufacturing network activities, and commercialization readiness.
• Develop and maintain multi-year CMC integrated plans covering milestones, critical path, dependencies, resources, budget, risks, and key decision points.
• Connect process development, analytical development, manufacturing, quality, supply chain, and regulatory activities into a single executable CMC plan in partnership with CMC Program Leaders and functional experts.
• Maintain plan integrity as 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 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.
• Provide transparent visibility of project status and performance; proactively identify 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 resolve complex project challenges.
• Support pre-alignment of program communications across Program Steering Committee, functional heads, and enterprise forums; help ensure CTTO presents one integrated position and escalate early to 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, including assumption-based resource demand submissions and forecast-versus-actual review.
• Provide accurate program-level information to support portfolio prioritization, resource decisions, scenario planning, and trade-off discussions.
• Maintain consistent portfolio visibility across schedule, milestones, risks, resources, and financials.
• Support assessment of 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.
• Use Microsoft Project, Smartsheet, PLANIT, and related platforms to improve planning discipline, data quality, and transparency.
• Apply 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: Director