Job Description
General Summary:
Cell, Gene and Biologics Therapies are a critical part of Vertex Pharmaceuticals, where research, development, and clinical manufacturing are highly integrated at our R&D site in Boston Seaport.
Vertex is seeking a highly skilled technical leader to join our Process Development organization and lead drug product process development for cell and gene therapies. Reporting to the Vice President, Process Development, this role will set the scientific and technical strategy for formulation, cryopreservation, frozen storage, thaw, fill and finish, and administration-ready product presentation. The Senior Director will guide programs from early development through commercialization and build an integrated drug product capability that supports robust product quality and reliable manufacturing with quality and the end patient in mind.
The ideal candidate brings deep experience in drug product development for cell and gene therapies, preferably spanning both autologous and allogeneic modalities. Candidates with strong biologics drug product experience and demonstrated ability to apply that expertise to advanced therapies will also be considered. This highly cross-functional leader will partner closely across process development, analytical development, manufacturing, MSAT, Quality, Regulatory, Clinical and Supply Chain.
The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a direct impact on our programs and patients. Our team brings together strong process design, scale-up, cryobiology, and advanced manufacturing technologies to enable successful implementation of cell, gene and biologics therapies.
Key Duties and Responsibilities:
Provide strategic, scientific, and organizational leadership for drug product process development across the cell and gene therapy portfolio. This includes drug product for allogeneic cell therapies as well as autologous gene-modified cell therapies
Establish and execute an integrated process development strategy from early clinical development through commercialization, aligned with overall CMC and program objectives
Lead process development, formulation and cryopreservation development, including selection and optimization of processing conditions, cryoprotectants, excipients, product concentration, hold conditions, freezing and thawing parameters, and storage and shipping conditions. For autologous therapies, this will also include activities such as, but not limited to, cell enrichment, activation, modification, culture, and harvesting
Oversee development of aseptic fill and finish processes for advanced therapies, including filling, container closure selection, frozen handling, inspection, labeling interfaces, and administration-ready product presentation
Define scalable and phase-appropriate drug product processes for both autologous and allogeneic therapies, accounting for their distinct manufacturing, logistics, dose, as well as chain-of-identity and chain-of-custody requirements
Ensure strong integration between upstream cell manufacturing and drug product operations, with clear understanding of how formulation, filling, freezing, shipping, thawing, and administration affect critical quality attributes and clinical performance
Drive process characterization, risk assessment, design space definition, control strategy development, validation readiness, and lifecycle management using Quality by Design principles
Lead technology transfer of drug product processes to internal GMP facilities and external partners, including transfer planning, process fit assessment, engineering runs, comparability support, and manufacturing readiness
Provide technical oversight for clinical and commercial manufacturing, investigations, change controls, deviations, process performance, and continuous improvement for drug product operations
Guide selection, qualification, and governance of CDMOs, equipment vendors, packaging suppliers,…