Senior Director, CMC Product Strategy (Cell Therapy)

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 238,000 - 357,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Senior Director, CMC Product Leader (T1D) to lead the CMC team for cell therapy programs, shaping development strategies, technology transfer, and regulatory readiness.

The role partners across BiopharmSci CGT, Manufacturing, Quality, Regulatory and Clinical to ensure GMP-compliant processes, scalable manufacturing, and timely submissions, with strong governance and budget oversight.

Qualifications

• Advanced degree and 10+ years in CMC development and manufacturing.
• Experience leading CMC programs and regulatory submissions.
• Strong cross-functional collaboration and program governance.

Responsibilities

• Develop and implement the integrated CMC strategy for assigned T1D cell therapy products.
• Lead cross-functional CMC team across development, analytical/ process development, scale-up, tech transfer, validation, and lifecycle planning.
• Serve on the Program Team to support planning, milestones, risk management, and decisions.
• Oversee development and optimization of scalable manufacturing processes for product quality and consistency.
• Guide technology transfer to manufacturing sites and support scale-up and readiness.
• Partner with Regulatory Affairs and Quality to develop CMC regulatory strategies and submissions.

Skills

CMC strategy

Cross-functional leadership

Regulatory and quality awareness

Risk management

Financial & project management

Stakeholder influence

Communication skills

Education

Advanced degree in Chemical Engineering/ Biotechnology

PhD or MBA preferred

Job description

Vertex Pharmaceuticals Incorporated is seeking a Senior Director, CMC Product Leader (T1D) to lead the CMC team for cell therapy programs, shaping development strategies, technology transfer, and regulatory readiness.

The role partners across BiopharmSci CGT, Manufacturing, Quality, Regulatory and Clinical to ensure GMP-compliant processes, scalable manufacturing, and timely submissions, with strong governance and budget oversight.