Senior Director, Process Development – CGT Drug Product

Role: 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: cell and gene therapies, autologous/allogeneic modalities, late-phase development, process transfer, regulatory interactions, manufacturing oversight. WorkSetup: on-site Boston, with minimal travel (~10%).