Director Cell Therapy CMC Program Lead – Late Stage

Position Summary

AstraZeneca’s Oncology R&D division explores innovative solutions to treat, prevent, and cure complex diseases. This role fuses data, technology, and science to drive breakthroughs in Cell Therapy. The Cell Therapy CMC Program Lead Director directs cross‑functional teams from inception to completion, overseeing product development, manufacturing, supply chain, and regulatory strategy. The position reports to the Head of CMC Cell Therapy Portfolio Strategy and is based in either Santa Monica, CA or Gaithersburg, MD.

• Build, grow, and mature the CMC function within Technical Operations.
• Must possess strong communication skills and be savvy working with technology, process development, analytical development, manufacturing, and business partners across the organization in a collaborative way.
• Prepare project team and steering committee materials related to their assigned projects and ensure project work aligns with established practices, policies, and processes.
• Project issues and risks must be identified and supervised and plans to resolve these issues must be developed and solutions implemented.
• Lead the strategic planning and execution of CMC programs for cell therapy products from early development through commercialization.
• Collaborate cross‑functionally with R&D, Manufacturing, Quality, Regulatory Affairs, and other departments to drive program success and alignment with business objectives.
• Develop and lead program timelines, budgets, and resources to meet project achievements and deliverables.
• Identify and anticipate CMC‑related risks/constraints to timing and resources.
• Provide strategic guidance and oversight for CMC‑related regulatory submissions, including IND, BLA, and other regulatory filings.
• Drive continuous improvement initiatives to optimize CMC processes, systems, and workflows.
• Lead and mentor a team of program managers and specialists to ensure commitment, collaboration, and professional development.
• Consistently maintain a positive & professional approach in communication, e.g. maintaining composure under pressure and leading up.
• Foster strong relationships with external partners, vendors, and team members to support program goals and objectives.
• Prepare and present program updates, reports, and strategic recommendations to senior management and key team members.
• Stay informed of industry trends, emerging technologies, and regulatory developments in cell therapy CMC to advise program strategies and decisions.
• Advises project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
• Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.
• Promote a culture of collaboration, cooperation, cross‑functional inclusion, execution excellence, effective communication, and cross‑functional problem‑solving to become a successful team.

• Provides leadership to the team and functional areas to anticipate and identify sophisticated project issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and completes corrective actions.
• Selects, evaluates and supports the development of direct reports.

• Minimum 12 years of experience with a BS/BA degree in a technical, engineering, or life sciences subject area.
• Minimum 10 years of experience with an MS/MA or MBA.
• Minimum 6 years of experience with a PhD.
• Minimum 8 years of leading projects/programs.
• Relevant CMC experience and knowledge of developing, manufacturing, and a thorough understanding of the Biotech or Cell Therapy industry, relevant regulations, and requirements.
• Experience leading matrix teams in a regulated environment.
• Authored CMC sections of NDA and / or MAA for an NBE.
• Thorough understanding of the drug development process.
• Experience with technical and scientific challenges such as applying novel assays for drug product release from pre‑IND to stage products.
• Willingness to occasionally travel for business purposes.

The annual base salary for this position ranges from $ –…