Senior Director, Process Development - CGT Drug Product

Job DescriptionGeneral 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 therapiesEstablish and execute an integrated process development strategy from early clinical development through commercialization, aligned with overall CMC and program objectivesLead 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 harvestingOversee development of aseptic fill and finish processes for advanced therapies, including filling, container closure selection, frozen handling, inspection, labeling interfaces, and administration-ready product presentationDefine 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 requirementsEnsure 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 performanceDrive process characterization, risk assessment, design space definition, control strategy development, validation readiness, and lifecycle management using Quality by Design principlesLead 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 readinessProvide technical oversight for clinical and commercial manufacturing, investigations, change controls, deviations, process performance, and continuous improvement for drug product operationsGuide selection, qualification, and governance of CDMOs, equipment vendors, packaging suppliers, and other strategic partners supporting drug product development and manufacturingPartner 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 attributesPartner 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 validationSupport preparation and review of CMC regulatory submissions, including INDs, BLAs, and MAAs, and serve as a technical representative in health authority interactions, audits, and inspectionsIdentify and implement innovative technologies that improve process performance, product recovery, consistency, robustness, closed processing, automation, throughput, and cost of goodsBuild, 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 improvementEstablish project plans, resource models, operating budgets, and external spendingCommunicate risks, tradeoffs, recommendations, and decisions clearly to program teams and senior leadershipExpected travel: no more than 10% domestic and international travelKnowledge and Skills:Proven ability to lead technical teams and complex cross-functional programs in a matrixed environmentExecutive presence, strategic judgment, and strong written and verbal communication skills, with the ability to influence decisions across scientific, technical, quality, regulatory, and business stakeholdersAbility to operate effectively in a fast-paced environment, manage competing priorities, and make clear, risk-based decisions amid scientific and operational ambiguityExperience working across teams to integrate drug product development with devices, administration systems, hospital or treatment-center workflows, and end-to-end cold-chain logistics is strongly recommendedTrack record of building new technical capabilities, laboratories, teams, or external networks to support a growing portfolioEducation and Experience:PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Cryobiology, Bioengineering or related discipline with commensurate years of education and experienceMinimum of 14+ years of experience in drug substance development and manufacturing. MS with 18+ years of relevant experience may be consideredExtensive industry experience in cell therapy and drug product process development, pharmaceutical development, technical operations, MSAT, or a related CMC function, with leadership scope appropriate for a Senior Director roleDemonstrated expertise in autologous cell therapy process development; cryopreservation and drug product development in various formats and presentations, including formulation, controlled-rate freezing or other scalable freezing approaches, frozen storage, shipping, thawing, and post-thaw handlingExperience developing robust formulation and fill and finish processes for cell and gene therapies is strongly preferred; highly relevant biologics drug product experience will be consideredExperience with both autologous and allogeneic cell and gene therapy products is strongly preferredDeep understanding of aseptic processing, contamination control, closed-system processing, container closure systems, extractables and leachables, particulate control, and product-contact materials as applied to advanced therapies or biologicsExperience advancing drug product processes from early development into late-phase development and commercialization, including process characterization, technology transfer, validation, and lifecycle managementExperience transferring processes to internal and external GMP facilities and providing technical oversight of such suppliersStrong knowledge of cGMP requirements and global regulatory expectations relevant to biologics and cell and gene therapy drug productsDemonstrated success authoring or reviewing CMC content for regulatory submissions and participating in health authority interactionsDirect experience with multiple cell and gene therapy modalities and product presentations, including both patient-specific and off-the-shelf products, is strongly preferredAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.Pay Range:$230,000 - $345,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:On-Site DesignatedFlex Eligibility Status:In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.#LI-OnsiteCompany InformationVertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io: Boston, MAType: Full time