Senior Director Manufacturing

Senior Director, CMC (Chemistry, Manufacturing & Controls)Our client is seeking a highly experienced CMC leader to take ownership of manufacturing strategy and execution across a next-generation cell therapy pipeline.This is a critical leadership role at the heart of translating science into scalable, high-quality, and regulatory-ready therapies.What You'll DoLead end-to-end CMC strategy across cell therapy manufacturing programsDrive CDMO evaluation, selection, and long-term partnership managementOversee tech transfer from process development into GMP manufacturingBuild and maintain a robust path toward scale-up and commercial readinessOwn CMC content for INDs and regulatory submissionsEnsure alignment between manufacturing, clinical timelines, and regulatory requirementsDrive continuous improvement in cost, quality, yield, and speed of manufacturing processesWhat We're Looking ForStrong background in biologics or cell therapy manufacturing (deep hands-on expertise required)Proven experience managing CDMOs and external manufacturing partnersTrack record supporting IND-stage or early clinical-stage programsExperience with tech transfer, GMP readiness, and scale-up of complex biologics or cell-based therapiesSenior Director-level experience in biotech or advanced therapeuticsStrong cross-functional leadership skills across CMC, Clinical, and Regulatory teamsWhy This RoleOwn the manufacturing backbone of a cutting-edge cell therapy pipelineDirectly influence speed, cost, and success of clinical developmentWork closely with executive leadership and technical foundersHelp build the infrastructure for late-stage and commercial readiness

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