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 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, 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 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 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 milestones 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 colleagues, 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.
• Governance, Stakeholder Alignment, and Enterprise VALUE
  • Serve as the primary CMC interface to relevant 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.

Required Qualifications:

• Advanced degree in sciences, engineering, pharmaceutical sciences, or a related discipline; doctoral-level training preferred.
• Minimum of 8 years of relevant experience with a PhD, 12 years with an MS, or 15 years with a BS, including significant experience leading complex, global, matrixed drug development programs or strategic assets.
• Demonstrated experience in development, manufacture, or commercialization of cell therapy, gene modified cell therapy, regenerative medicine products, ATMPs, CAR-T, TCR-T, stem cell therapies, or related advanced therapeutic modalities.
• Strong understanding of allogeneic manufacturing platforms, cell processing technologies, cryopreservation strategies, and cell therapy supply chains.
• Experience developing CMC strategies for complex biological products with significant process-product interdependence and limited opportunities for traditional analytical characterization.
• Knowledge of global ATMP, cell therapy, and biologics regulatory requirements, including FDA, EMA, PMDA, and applicable regional expectations.
• Demonstrated success in product development, CMC leadership, enterprise program leadership, or asset leadership with accountability for strategy, execution, budget, governance, and cross-functional outcomes.
• Broad understanding of the end-to-end development continuum, including CMC, technical development, clinical development, regulatory strategy, manufacturing, quality, supply chain, launch readiness, commercialization and LOE management.
• Strong financial and business acumen, including experience with budget stewardship, investment decisions, resource prioritization, business case development, enhancing supply chain performance and resilience and VALUE optimization.
• Exceptional communication, synthesis, negotiation, stakeholder management, and team leadership skills

Preferred Qualifications:

• Experience leading commercialization readiness activities for cell therapy or ATMP products.
• Experience with cell therapy manufacturing network design, technology transfer, facility start-up, CDMO oversight, or commercial manufacturing implementation.
• Demonstrated strategic understanding of the competitive landscape, including competitor pipelines, market dynamics, and key differentiation opportunities.
• Track record of influencing senior leaders, governance bodies, investment forums, external partners, and health authorities in high-stakes, ambiguous environments.
• Experience leading alliance relationships, outsourced networks, CDMOs, vendors, or other external partnerships in support of program execution.
• Experience leading assets from early development through first approval, launch, or post-approval lifecycle management.
• Experience presenting in portfolio governance, investment committee, executive leadership, or board adjacent decision forums.
• Demonstrated ability to operate credibly across multiple therapeutic areas, modalities, or technical platforms.
• Proven success building high-performing teams and strengthening enterprise leadership capability.
• Experience managing seamless transition from development to commercial operations, including product knowledge transfer, lifecycle planning, commercial supply readiness, and product discontinuation.

Location and Working Environment

This position is based in Westborough, MA.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines and international stakeholders

• Highly matrixed environment requiring cross-regional coordination.
• Frequent interaction with senior leadership and governance bodies.
• Collaboration across EU, US, and Japan time zones.

Salary Range

$199,220 - $284,600 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

#LI-SS