CMC Product Leader, Senior Director - T1D

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** General

Summary:

**### 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 Biopharm Sci 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.  ###
** Key

Duties and 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 Biopharm Sci 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 Biopharm Sci 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  ###
** Knowledge and

Skills:

**  * ### 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,…