Drug Product CMC Director
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