Director, CMC Product Lead

Role: CMC Product Lead overseeing development strategies for multiple assets from initial human trials through pivotal stages, ensuring alignment with TPP and QTPP, and managing cross-functional technical plans. Responsibilities: define and communicate CMC strategies, translate program goals into actionable plans, serve as a key decision-maker in program teams, lead technical discussions, contribute to regulatory submissions, and manage resources and budgets. Requirements: PhD with 10+ years, or MS with 12+ years, in relevant scientific fields; proven leadership in biotech/pharma CMC or product development; deep knowledge of Technical Development, Manufacturing, Quality, and Regulatory CMC activities. Preferred: advanced technical depth, stakeholder influence, and strategic leadership skills; experience in biologics, cell/gene therapies, or novel modalities; and familiarity with global regulatory processes. High-Value: senior-level (10+ years), strategic CMC leadership, cross-functional influence, technical storytelling, and experience managing complex programs across therapeutic areas. Work Setup: not specified; role involves collaboration with manufacturing sites and cross-functional teams.