Hybrid Strategic CMC Lead, Cell Therapy

Astellas; Westborough (MA); Hybrid; USD 199,000 - 285,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Annual Bonus

LT Incentive Plan

Fleet Vehicle

Paid Time Off

Job summary

Astellas is seeking a Strategic CMC Lead, Cell Therapy (Sr. Director) to drive end-to-end CMC strategy for cell therapy assets from clinical proof of concept to launch and lifecycle management.

The role requires leading cross-functional teams across manufacturing, regulatory, quality, supply chain, and commercial to maximize VALUE and patient impact, shaping asset strategy and ensuring timely decisions.

Qualifications

• Advanced degree in sciences, engineering, pharmaceutical sciences, or related field; doctoral-level training preferred.
• 8+ years leading global, matrixed cell therapy or ATMP programs; 12 years with MS or 15 years with BS; strong leadership experience.
• Experience developing CMC strategies for complex biological products with significant process-product interdependence.
• Knowledge of FDA/EMA/PMDA regulatory requirements for ATMPs and cell therapy products.
• Exceptional communication, synthesis, negotiation, and stakeholder management skills.

Responsibilities

• Define, own and implement the integrated CMC asset strategy across lifecycle stages.
• Lead the cross-functional VALUE team for asset strategy, governance, and risk trade-offs.
• Drive development of scalable cell therapy manufacturing strategies including capacity planning and supply readiness.
• Develop and implement CMC regulatory strategies and submission roadmaps with quality and regulatory partners.
• Ensure quality, risk management, and VALUE considerations across drug development, manufacturing and launch readiness.
• Manage budgets, governance, and resource plans with senior leadership.

Skills

Strategic leadership

Cross-functional collaboration

CMC strategy

Cell therapy knowledge

Regulatory affairs

Education

PhD in sciences/engineering

MS in related field

BS in related field

Job description

Astellas is seeking a Strategic CMC Lead, Cell Therapy (Sr. Director) to drive end-to-end CMC strategy for cell therapy assets from clinical proof of concept to launch and lifecycle management.

The role requires leading cross-functional teams across manufacturing, regulatory, quality, supply chain, and commercial to maximize VALUE and patient impact, shaping asset strategy and ensuring timely decisions.