Global Cell Therapy CMC Strategy Lead

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

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) match and company contribution

Annual Corporate Bonus

Long Term Incentive Plan

Hybrid work arrangement

Job summary

Astellas Pharma, Inc. is seeking a CMC Lead to drive the integrated strategy for cell therapy assets from concept through late-stage trials and launches. You will partner across manufacturing, regulatory, quality, and supply chain to maximize VALUE and ensure timely execution.

The role requires an advanced science degree and a track record of leading complex, global programs, with strong leadership and strategic communication skills. Hybrid work in Westborough, MA is offered.

Qualifications

• Advanced degree in sciences, engineering, pharmaceutical sciences or related discipline (doctoral preferred).
• Minimum 8+ years leading global drug development programs or strategic assets.

Responsibilities

• Define and lead integrated CMC asset strategy and lifecycle objectives.
• Lead cross-functional VALUE Team to align drug substance, product, analytical, regulatory, quality and supply.
• Oversee manufacturing strategy, network planning, and readiness for clinical to commercial transitions.
• Develop and implement regulatory CMC strategies and ensure compliant submission content.

Skills

Cross-functional leadership

CMC strategy

Regulatory strategy

Asset leadership

Budget & governance

Strategic communication

Education

Advanced degree in sciences or engineering

Job description

Astellas Pharma, Inc. is seeking a CMC Lead to drive the integrated strategy for cell therapy assets from concept through late-stage trials and launches. You will partner across manufacturing, regulatory, quality, and supply chain to maximize VALUE and ensure timely execution.

The role requires an advanced science degree and a track record of leading complex, global programs, with strong leadership and strategic communication skills. Hybrid work in Westborough, MA is offered.