Senior Director, Process Development – CGT Drug Product

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, and other strategic partners supporting drug product development and manufacturing Partner with Analytical Development to establish phase-appropriate methods and studies that assess identity, potency, viability, recovery, stability, particulate risk, container closure integrity, and other relevant drug product quality attributes Partner with Quality, Regulatory, Manufacturing, and Supply Chain to establish compliant strategies for aseptic processing, contamination control, raw and ancillary materials, viral and biosafety risk, shipping validation, stability, and process validation Support preparation and review of CMC regulatory submissions, including INDs, BLAs, and MAAs, and serve as a technical representative in health authority interactions, audits, and inspections Identify and implement innovative technologies that improve process performance, product recovery, consistency, robustness, closed processing, automation, throughput, and cost of goods Build, lead, and develop a high-performing team of scientists and engineers; establish clear accountabilities, strengthen technical depth, and create a collaborative culture of scientific rigor and continuous improvement Establish project plans, resource models, operating budgets, and external spending Communicate risks, tradeoffs, recommendations, and decisions clearly to program teams and senior leadership Expected travel: no more than 10% domestic and international travel Knowledge and Skills: Proven ability to lead technical teams and complex cross-functional programs in a matrixed environment Executive presence, strategic judgment, and strong written and verbal communication skills, with the ability to influence decisions across scientific, technical, quality, regulatory, and business stakeholders Ability to operate effectively in a fast-paced environment, manage competing priorities, and make clear, risk-based decisions amid scientific and operational ambiguity Experience working across