Senior Director, Cell & Gene Therapy Process Development

Scorpion Therapeutics; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Vertex is seeking a Senior Director of Process Development for Cell, Gene, and Biologics Therapies to lead drug product process development from early clinical to commercialization. You will shape strategy for formulation, cryopreservation, fill-finish, and product presentation, and oversee autologous and allogeneic programs.

This role requires a PhD with 14+ years of industry experience and deep expertise in cGMP, regulatory submissions, and process validation.

Qualifications

• PhD with 14+ years of industry experience and leadership in cell and gene therapy process development.
• Deep expertise in formulation, cryopreservation, aseptic fill-finish, and drug product characterization.
• Extensive knowledge of cGMP, regulatory submissions, and process validation.
• Experience with autologous and allogeneic modalities and biologics.

Responsibilities

• Establish and execute integrated strategies for formulation, cryopreservation, fill-finish, and product presentation.
• Oversee development activities for autologous and allogeneic therapies.
• Ensure compliance with cGMP and regulatory standards.
• Partner with analytical, manufacturing, quality, regulatory, and supply chain teams.
• Lead technology transfer, continuous improvement, and innovative technology integration.
• Build and develop a high-performing team.

Skills

Leadership

Formulation

Cryopreservation

Aseptic fill-finish

Drug product characterization

cGMP

Regulatory submissions

Process validation

Autologous/allogeneic modalities

Biologics

Education

PhD in relevant field

Job description

Vertex is seeking a Senior Director of Process Development for Cell, Gene, and Biologics Therapies to lead drug product process development from early clinical to commercialization. You will shape strategy for formulation, cryopreservation, fill-finish, and product presentation, and oversee autologous and allogeneic programs.

This role requires a PhD with 14+ years of industry experience and deep expertise in cGMP, regulatory submissions, and process validation.