Director of CMC Technical Leadership

Job Summary

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