Drug Product CMC Director

Job Summary

To support innovative pharmaceutical development, the full-time remote CMC Director - Drug Product will manage formulation development, oversee manufacturing processes, and ensure regulatory compliance for small-molecule oral solid dose drug products.

Key responsibilities

• Lead formulation development, scale-up, and tech transfer for drug product manufacturing, collaborating with external CDMOs and internal teams
• Provide strategic leadership for drug product development from pre-IND through Phase 3, ensuring compliance with regulatory guidelines
• Serve as the technical authority for OSD formulation development and act as the main contact for health authority discussions

Required qualifications

• Extensive experience in CMC-related activities for small-molecule oral solid dose drug products
• Proven track record of managing drug product development strategies through various clinical phases
• Strong knowledge of global regulatory guidelines and cGMP regulations
• Experience in preparing and reviewing CMC documentation for regulatory submissions
• Ability to work cross-functionally with Regulatory Affairs and Quality Assurance teams