CMC Product Leader, Senior Director - T1D

Vertex Pharmaceuticals seeks a Senior Director to lead Chemistry, Manufacturing, and Controls strategy for Type 1 Diabetes cell therapy products. The role involves developing integrated CMC plans across development, scale-up, regulatory submission, and commercialization while partnering across functional teams in a matrixed organization.

Responsibilities

• Develop and execute integrated CMC strategy for assigned T1D cell therapy products aligned with development goals
• Lead cross-functional CMC team coordinating process development, analytical development, scale-up, and technology transfer activities
• Partner with regulatory and quality functions to develop CMC regulatory strategies and prepare regulatory submissions
• Guide technology transfer to manufacturing sites and support production readiness and manufacturing execution
• Identify, assess, and mitigate technical, regulatory, quality, supply, timeline, and execution risks affecting product development

Requirements

• Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related discipline; PhD or MBA preferred
• 10+ years CMC development and manufacturing experience in biotechnology or pharmaceutical industry
• Significant experience in cell therapy or regenerative medicine product development
• Director or Senior Director level experience leading cross-functional teams or major programs
• Deep knowledge of GMP requirements, quality systems, and global regulatory standards for cell therapies
• Proven track record supporting cell therapy development, regulatory advancement, and commercialization
• Experience with technology transfer, scale-up, validation, and manufacturing readiness for complex products

Compensation: $237,000+