Senior Director, Process Development - CGT Drug Product

Vertex Pharmaceuticals seeks a Senior Director to lead drug product process development for cell and gene therapies at their Boston R&D site. The role encompasses formulation, cryopreservation, fill-and-finish, and commercialization strategy across autologous and allogeneic modalities, requiring deep technical expertise and cross-functional leadership.

Responsibilities

• Establish and execute integrated drug product process development strategy from clinical development through commercialization
• Lead formulation, cryopreservation, and aseptic fill-and-finish process development and optimization
• Drive process characterization, risk assessment, design space definition, and control strategy using Quality by Design
• Oversee technology transfer of drug product processes to internal and external manufacturing partners
• Build, lead, and develop high-performing team of scientists and engineers across drug product operations

Requirements

• Deep experience in drug product development for cell and gene therapies
• Demonstrated expertise with autologous and/or allogeneic therapy modalities
• Strong biologics drug product background applicable to advanced therapies
• Proven ability to lead technical teams in matrixed environments
• Executive presence with strategic judgment and cross-stakeholder influence
• Experience with formulation, cryopreservation, fill-and-finish process development
• Knowledge of Quality by Design principles and regulatory CMC strategies