Senior Director, CMC Strategy & Cell Therapy

astellas; Massachusetts; On-site; USD 199,000 - 285,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Bonuses

Job summary

Astellas is seeking a CMC Lead to drive the asset strategy for cell therapy programs from clinical proof of concept to launch and lifecycle transition. You will lead a cross-functional team across manufacturing, analytical, regulatory, quality, and supply chain, shaping strategy and delivering high-impact VALUE creation.

The role requires an advanced degree with senior leadership experience in cell therapy or ATMPs, strong governance, and global regulatory knowledge.

Qualifications

• Advanced degree in sciences or engineering; doctoral level preferred.
• Minimum of 8 years of relevant experience with a PhD, 12 with MS, or 15 with BS in global drug development leadership.
• Experience leading cell therapy, ATMPs, or related modalities.
• Knowledge of global ATMP, cell therapy regulatory requirements (FDA/EMA/PMDA).
• Proven success leading asset strategy, governance and cross-functional outcomes.

Responsibilities

• Define and implement integrated CMC asset strategy aligned with development and launch plans.
• Lead cross-functional VALUE Team across manufacturing, regulatory, quality, and supply chain.
• Develop scalable manufacturing, process transfer, and lifecycle management strategies.
• Ensure regulatory submissions are robust, compliant, and aligned with QA standards.
• Drive budget, governance, and cross-functional risk management for asset VALUE.

Skills

Leadership

Cross-functional

Strategic thinking

Communication

Education

Advanced degree in sciences

PhD preferred

Job description

Astellas is seeking a CMC Lead to drive the asset strategy for cell therapy programs from clinical proof of concept to launch and lifecycle transition. You will lead a cross-functional team across manufacturing, analytical, regulatory, quality, and supply chain, shaping strategy and delivering high-impact VALUE creation.

The role requires an advanced degree with senior leadership experience in cell therapy or ATMPs, strong governance, and global regulatory knowledge.