CMC Product Leader, Senior Director - T1D

Vertex Pharmaceuticals•Boston, MA

7d•Hybrid

About The Position

The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing, and Controls (CMC) functional team supporting cell therapy products within Biopharmaceutical Sciences - Cell & Gene Therapy. The role is accountable for developing and executing integrated CMC strategies across development, scale-up, technology transfer, validation, regulatory submission, and commercialization readiness. As the CMC representative on the Program Team, a sub-team of the Disease Strategy Team, the CMC Product Leader will partner across BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical, Commercial, Finance, and other functions to align CMC plans with broader product objectives. The successful candidate will provide strategic and technical leadership, guide governance and decision-making, manage program risks and resources, and enable delivery of high-quality cell therapy products.

Requirements

Deep knowledge of CMC development and manufacturing for cell therapy, regenerative medicine, or other complex biologic products
Strong understanding of process development, analytical development, scale-up, technology transfer, process validation, manufacturing, and product lifecycle considerations
In-depth knowledge of GMP requirements, quality systems, and global regulatory expectations relevant to cell therapy products
Demonstrated ability to translate scientific, technical, regulatory, and business considerations into an integrated CMC strategy and executable plan
Strong strategic thinking, judgment, problem-solving, and risk-management skills, with the ability to make decisions in situations of uncertainty
Proven leadership of cross-functional teams and complex programs in a matrix environment without relying solely on direct authority
Ability to influence senior stakeholders, navigate governance processes, and communicate concise recommendations, trade-offs, and decisions
Excellent written, verbal, facilitation, and interpersonal communication skills
Demonstrated ability to build productive partnerships across R&D, Manufacturing, Quality, Regulatory, Clinical, Commercial, Finance, and external organizations
Strong financial and project management capabilities, including budget, resource, milestone, dependency, and performance tracking
Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline. PhD or MBA preferred
10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry, with significant experience in cell therapy or regenerative medicine
Demonstrated experience leading a function, department, cross-functional CMC team, or major development program at the Director or Senior Director level
Experience in process development, analytical development, manufacturing, or a closely related CMC discipline is strongly preferred.
Proven track record supporting successful development, regulatory advancement, and commercialization readiness of cell therapy products
Experience with CMC regulatory submissions and interactions with regulatory agencies
Experience leading technology transfer, scale-up, validation, and manufacturing readiness activities for complex products

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
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.

Responsibilities

Develop and implement the integrated CMC strategy for assigned T1D cell therapy products, ensuring alignment with product development and commercialization goals
Lead the cross-functional CMC functional team and coordinate activities across process development, analytical and method development, device development when required, scale-up, technology transfer, validation, manufacturing readiness, and lifecycle planning
Serve as a key member of the Program Team, providing CMC expertise and recommendations to support integrated planning, milestone delivery, risk management, and strategic product decisions
Partner with BiopharmSci CGTR functional leaders and subject matter experts to oversee development and optimization of robust, scalable manufacturing processes that support product quality and consistency
Guide technology transfer to manufacturing sites and support scale-up, production readiness, and successful execution of manufacturing activities
Partner with Regulatory Affairs and Quality to develop CMC regulatory strategies, lead preparation of CMC content for regulatory submissions, and support responses to agency questions and inspections
Ensure CMC plans and activities are consistent with applicable Good Manufacturing Practice requirements, quality expectations, and regulatory standards for cell therapy products
Lead CMC project and decision approval processes through BSMO and applicable Vertex governance committees, presenting clear options, recommendations, risks, and resource implications
Facilitate effective CMC team meetings and maintain clear communication of strategy, progress, decisions, interdependencies, risks, and business needs across stakeholders
Develop CMC budgets and resource plans in partnership with BiopharmSci functions and Finance; monitor milestones, key performance indicators, costs, and resource utilization
Proactively identify, assess, and mitigate technical, regulatory, quality, supply, timeline, and execution risks that could affect product development or commercialization
Build strong cross-functional relationships and foster an accountable, collaborative, and inclusive team environment in a highly matrixed organization