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.

• 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

• 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 teams to integrate drug product development with devices administration systems hospital or treatment-center workflows and end-to-end cold-chain logistics is strongly recommended
• Track record of building new technical capabilities laboratories teams or external networks to support a growing portfolio

• PhD in Chemical Engineering Biochemical Engineering Pharmaceutical Sciences Cryobiology Bioengineering or related discipline with commensurate years of education and experience
• Minimum of 14 years of experience in drug substance development and manufacturing. MS with 18 years of relevant experience may be considered
• Extensive 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 role
• Demonstrated 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 handling
• Experience developing robust formulation and fill and finish processes for cell and gene therapies is strongly preferred; highly relevant biologics drug product experience will be considered
• Experience with both autologous and allogeneic cell and gene therapy products is strongly preferred
• Deep 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 biologics
• Experience advancing drug product processes from early development into late-phase development and commercialization including process characterization technology transfer validation and lifecycle management
• Experience transferring processes to internal and external GMP facilities and providing technical oversight of such suppliers
• Strong knowledge of cGMP requirements and global regulatory expectations relevant to biologics and cell and gene therapy drug products
• Demonstrated success authoring or reviewing CMC content for regulatory submissions and participating in health authority interactions
• Direct experience with multiple cell and gene therapy modalities and product presentations including both patient-specific and off-the-shelf products is strongly preferred

At 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:

Disclosure Statement:

Flex Designation:

Flex 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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex 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 persons 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