Strategic CMC Lead,Cell Therapy (Sr. Director Job Westborough area,Massachusetts USA,Management

Position: Strategic CMC 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

About Astellas

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 CMC activities supporting the end-to-end advancement and VALUE maximization of one or more strategic Cell Therapy assets from clinical proof of concept (POC) to late-stage clinical trials, BLA filing, major product launch, and lifecycle transition. The CMC Lead serves as the single, integrated voice for pharmaceutical product development, manufacturing and supply within the asset maximization team, while also helping to shape asset strategy, driving alignment across assets and with enterprise goals, and ensuring high-quality execution across pharmaceutical research and development, manufacturing, regulatory, quality, supply chain, commercial, finance, and relevant external partner work streams.

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, 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 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 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.
Cell Therapy Manufacturing and Commercialization
Accountable for development and execution of the cell therapy manufacturing strategy, including clinical-to-commercial transition, capacity planning, manufacturing network strategy, and commercial supply readiness.
Lead the development of scalable, robust, and commercially viable manufacturing processes, including implementation of automation, closed-system processing, digitalization, and process standardization strategies.
Lead development of long-term raw materials, starting materials, and critical reagent strategies, including supplier qualification, business continuity, and supply risk mitigation in consideration of regulatory guidelines.
Ensure development of phase-appropriate potency, comparability, and control strategies that support process changes, technology transfers, validation, licensure, and lifecycle management.
Accountable for development and implementation of MCB and WCB control strategy including characterization, stability plan, and…