Director of CMC Technical Leadership

A company is looking for a Director, CMC Technical Product Leadership.

Key Responsibilities Create and maintain CMC project plans for late phase or commercial CMC strategy Collaborate with the Quality Product Lead to drive cross-functional CMC strategy and ensure seamless transition to commercial manufacturing Manage the CMC risk register and oversee mitigation projects in collaboration with various stakeholders

Required Qualifications B.S., M.S., or Ph.D. in a scientific or engineering discipline 9+ years of experience in Manufacturing, MSAT, or Process Development for biologics/cell therapies 4+ years leading cross-functional teams or direct reports Experience in late-stage or commercial cell and gene therapy Solid understanding of cGMP regulations and global regulatory expectations for biologics