Analytical CMC Strategy Associate DirectorJob Description General Summary: Vertex Pharmaceuticals is seeking a highly motivated, collaborative, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership within and across functional areas. The Analytical CMC Strategy Associate Director is the primary analytical liaison for their program(s) and will lead, coordinate, monitor, and collaborate cross-functionally to develop analytical CMC strategies while also providing tactical direction for the execution of the analytical project plan. This is a key leadership position where the incumbent will communicate and execute the analytical strategy and will involve routine interaction with senior management. In this matrix leadership role, the candidate will act as the Analytical Product Lead (APL) and have primary responsibility for overseeing programs through the late-stage drug development lifecycle, Marketing Authorization/Biologics Licensure application (MAA/BLA), and Life Cycle management.
Key Duties and Responsibilities: Leading the development of the analytical CMC strategy for specific product(s), project planning, setting priorities, establishing team goals, and assuring both timeliness and high quality of deliverables for late-stage and commercial programs.Providing scientific leadership within and across functional areas to develop and successfully execute, in conjunction with the analytical development and Life cycle management functional areas, an analytical strategy to support product commercialization.Contributing to the regulatory CMC strategy and the preparation of global regulatory submissions, with clear and accurate source documentation, for the late-stage and commercial program(s) in analytical CMC subject areas including registrational CQAs, control strategy and justification of specifications, and comparability studies according to subject matter understanding and regulatory guidelines.Representing the commercial team at the program level and internal governance bodies. Establish and communicate analytical program goals, key issues and risks, and ensure operational plans are in place to execute the analytical strategy for the program(s). Identify, and escalate key issues and risks to the program team and management.Build and maintain strong collaborations across the organization, including key stakeholders in commercial and development functions, Regulatory and Quality teams, peers, and senior management.Identify and implement improvements that optimize product development and commercial supply processes.Knowledge and Skills: Must have experience with cell and gene therapy or biologics CMC development (CQAs, specifications, comparability) from late-stage development to commercialization. Experience with devices and/or oligonucleotides is a plus.Demonstrate an in-depth understanding of analytical techniques used for cell and gene therapy products and knowledge of the cGMPs, USP/ICH, and regulatory guidance for commercial-stage products.Strong technical and regulatory writing skills. Must have direct experience with authoring eCTD Module 3 sections of commercial regulatory submissions (MAA/BLA and PASs) and responding to health authority queries.Strong strategic thinking capabilities with a forward-looking perspective and demonstrated learning agility with a drive to solve problems.Strong leadership and collaboration skills with the ability to collaborate with an interdisciplinary team with excellent written and oral communication skills.Excellent organizational, program management, and planning skills; adaptive learning, critical thinking, and the ability to work well in a team.High proficiency in Word, Excel, and PowerPoint. Knowledge of SmartSheets and statistical software (JMP, Prism) a plus.Education and Experience: Ph.D. (or equivalent degree) in protein chemistry, analytical chemistry, or a relevant scientific discipline and 7+ years experience in the biopharmaceutical industry, ORM.S. (or equivalent degree) in protein chemistry, analytical chemistry, or a relevant scientific discipline and 10+ years of experience in the biopharmaceutical industry, ORB.S. (or equivalent degree) in protein chemistry, analytical chemistry, or a relevant scientific discipline and 12+ years of experience in the biopharmaceutical industry.
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