CMC Product Management Lead Cell Therapy Sr. Director

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

This role works within a cross-functional Asset Maximization Team and is accountable for the CMC activities supporting the end-to-end advancement and VALUE maximization of one or more strategic assets from development candidate nomination through product registration, major product launch, and lifecycle transition. The CMC leader serves as the single, integrated voice for CMC product development, manufacturing and supply within the Asset Maximization Team, while also shaping asset strategy, driving alignment across assets and with enterprise goals, and ensuring high-quality execution across product research and development, manufacturing, regulatory, quality, supply chain, commercial, finance, and external partner workstreams. The role translates scientific, technical, operational, and business complexity into clear strategic options, risk-based recommendations, and executable plans that maximize patient impact, portfolio VALUE, and speed to decision.

Responsibilities and Accountabilities:

Strategy and Asset Leadership

• Define, own and implement the integrated CMC asset strategy, ensuring alignment with target product profile, quality target product profile, clinical development plan, regulatory strategy, commercialization and launch plan, and lifecycle objectives.
• Serve as the primary product development, manufacturing and supply representative on the asset maximization team, providing strategic input into asset plans, governance decisions, investment choices, and differentiating VALUE creation opportunities.
• Holds accountability for the product strategy and product innovation ensuring alignment with the quality target product profile and lifecycle objectives
• Accountable for managing and optimizing COGM to enhance product VALUE, profitability, and lifecycle sustainability
• Translate complex scientific, technical, CMC regulatory, quality, manufacturing, supply chain, and commercial considerations into clear options, trade-offs, and implications for timelines, cost, quality, risk, and asset VALUE.

Integrated Execution and Delivery

• Lead the cross-functional Product VALUE Team, integrating drug substance, drug product, analytical, CMC regulatory, quality, manufacturing, supply chain, finance, intellectual property and external partner workstreams.
• Convert the integrated CMC asset strategy into fit-for-purpose integrated plans with clear milestones, dependencies, resource requirements, budget assumptions, risk mitigation pathways, and decision points.
• Lead the manufacturing site selection ensuring alignment with the clinical development plan, commercialization and launch plans as well as with the PDM Supply Network Strategy.
• Maintain clear end-to-end accountability for the overall control strategy including integrated CMC risk management of the asset across the patient axis in accordance with ICH Q8-Q11 principles and enterprise criteria
• Drive delivery of phase-appropriate CMC development strategies consistent with Asset Maximization Team goals, regulatory expectations, launch readiness, and enterprise portfolio priorities.
• Manage integrated CMC and asset-level budget and resource forecasts in partnership with functional leaders, ensuring disciplined prioritization and investment quality.

Regulatory, Quality, and Technical Integrity

• Co-develop CMC regulatory strategy in close partnership with CMC regulatory, representing product development and CMC perspectives in health authority meetings and pre-submission interactions.
• Ensure CMC activities, control strategy, submission content, product risk assessments, and regulatory filing roadmaps are scientifically robust, phase-appropriate, compliant, and aligned to quality expectations.
• Maintain accountability for the quality, completeness, and strategic coherence of CMC submission content, including Module 3 and equivalent regional requirements.

Governance, Stakeholder Alignment, and Enterprise VALUE

• Serve as the primary CMC interface to governance bodies, senior leaders, and alliance governance; present concise recommendations, decision options, risks, and implications for asset VALUE.
• Drive alignment across functions, geographies, regions, and partners by eliminating silos, accelerating decision-making, and ensuring consistent execution against the integrated strategy.
• Anticipate and resolve cross-functional risks and issues, escalating transparently through governance when decisions, resources, or trade-offs are required.
• Represent the asset or program externally with alliance partners, CDMOs, vendors, regulators, key experts, and relevant stakeholder communities, ensuring credible, compliant, and consistent communication.

Capability Development

• Contribute to developing enterprise capability by mentoring POD and VALUE team members, strengthening team effectiveness, and embedding high standards for execution, governance, quality, and VALUE creation and delivery.
• Partner with functional leaders to support growth, development, and readiness of team members contributing to asset and product development outcomes.