Strategic CMC Lead, Cell Therapy (Sr. Director

CMC Lead, Cell Therapy

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 long-term manufacturing plan.
  • Accountable for development and optimization of the commercialization business model, including cost-of-goods reduction strategies, manufacturing yield improvement, supply chain resilience, and launch readiness planning.
• 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 work streams.
  • 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 CMC risk management of the asset across the patient axis in accordance with ICH Q9 and enterprise criteria
  • Drive delivery of phase-appropriate CMC and asset…