Senior CMC Program Manager, Cell Therapy

AstraZeneca plc; Santa Monica (CA); On-site; USD 137,000 - 205,000; Full time

Job summary

AstraZeneca plc in Santa Monica, CA seeks an Associate Director, Cell Therapy CMC Project Manager to lead cross-functional CMC planning, governance, and risk management within the Cell Therapy Technical Operations portfolio.

You will translate development strategies into integrated, phase-appropriate plans, manage changes, and drive execution with program leaders and function heads to ensure regulatory readiness and commercialization milestones.

Qualifications

• Bachelor's, Master's, or PhD in a relevant scientific, engineering, or technical discipline, or equivalent industry experience.
• 10+ years of relevant experience 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, preferably including autologous, allogeneic, or in vivo approaches.
• Understanding of drug-product/process development, analytical development, regulatory expectations, and/or supply chain within a CMC environment.

Responsibilities

• 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.

Skills

Cross-functional leadership

Strategic execution

Risk management

Stakeholder influence

Communication skills

Education

Bachelor's degree

Master's or PhD (preferred)

Tools

Microsoft Project

Smartsheet

PLANiT

Job description

AstraZeneca plc in Santa Monica, CA seeks an Associate Director, Cell Therapy CMC Project Manager to lead cross-functional CMC planning, governance, and risk management within the Cell Therapy Technical Operations portfolio.

You will translate development strategies into integrated, phase-appropriate plans, manage changes, and drive execution with program leaders and function heads to ensure regulatory readiness and commercialization milestones.