Senior Director CMC

Job Summary

Leading project progression and client interactions, the remote Senior Director CMC will manage CMC activities supporting IND and BLA submissions, provide strategic guidance for project teams, and enhance business development efforts.

Key responsibilities:

• Provide technical and portfolio leadership for CMC projects, ensuring timely and budget-compliant execution
• Serve as a decision-maker for technical issues, facilitating communication and alignment between teams and clients
• Support corporate business development by enhancing service offerings and developing new client relationships

Required qualifications:

• PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering, or a related discipline
• A minimum of 8-20 years of relevant experience in the pharmaceutical or biotech industry
• Working knowledge of regulations and industry trends for large molecule and ADC product development
• Experience in writing regulatory documents and managing multiple CMC projects simultaneously
• Biologics manufacturing experience is preferred, along with strong project management and interpersonal skills