CMC Product Leader Senior Director, Hybrid Cell Therapy

MFS Investments; Boston (MA); Hybrid; USD 238,000 - 357,000; Full time

Benefits offered by this job

Hybrid work eligibility

Job summary

Vertex Pharmaceuticals seeks a Senior Director, CMC Product Leader (T1D) to drive the integrated CMC strategy for cell therapy programs. You will lead a cross-functional team spanning process development, analytics, device development, scale-up, transfer, validation, and regulatory readiness.

You will partner with Regulatory, Quality, Manufacturing, and Clinical teams to ensure lifecycle planning, risk management, and strategic product decisions align with development and commercialization goals.

Qualifications

• Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related discipline; PhD or MBA preferred.
• 10 years of experience in CMC development and manufacturing within biotech/pharma.
• Experience leading a function/department or major development program at Director/Senior Director level.

Responsibilities

• Develop and implement the integrated CMC strategy for T1D cell therapy products.
• Lead cross-functional CMC team across development, transfer, validation, and lifecycle planning.
• Partner with Regulatory and Quality to develop CMC regulatory strategies and submissions.

Skills

CMC strategy

Cross-functional leadership

Regulatory strategy

Process development

GMP compliance

Education

Advanced degree in Chemical Engineering/Biotechnology/Biochemistry (PhD or MBA preferred)

10 years in CMC development/manufacturing

Job description

Vertex Pharmaceuticals seeks a Senior Director, CMC Product Leader (T1D) to drive the integrated CMC strategy for cell therapy programs. You will lead a cross-functional team spanning process development, analytics, device development, scale-up, transfer, validation, and regulatory readiness.

You will partner with Regulatory, Quality, Manufacturing, and Clinical teams to ensure lifecycle planning, risk management, and strategic product decisions align with development and commercialization goals.