Senior Director, Process Development – CGT Drug Product

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

Senior Director of Process Development for Cell, Gene, and Biologics Therapies at Vertex, leading drug product process development from early clinical to commercialization.

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

Requirements

• PhD in relevant field with 14+ years industry experience, including 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

High Value Areas

• cell and gene therapies
• autologous/allogeneic modalities
• late-phase development
• process transfer
• regulatory interactions
• manufacturing oversight

Work Setup

on-site Boston, with minimal travel (~10%).