Director of Drug Substance Operations

Job Summary

Leading the operational oversight of external drug substance manufacturing, the remote Director of Drug Substance Operations will ensure reliable supply from Contract Manufacturing Organizations (CMOs) while driving performance through governance and KPI management.

Key responsibilities

• Provide end-to-end operational leadership and oversight of CMOs to ensure compliant drug substance supply
• Establish and maintain robust CMO governance frameworks and drive performance against key operational KPIs
• Build strategic relationships with CMO leadership teams to enable issue resolution and long-term performance

Required qualifications

• Bachelor's or advanced degree in Science, Engineering, or related discipline
• Significant experience in pharmaceutical or biotech operations, including external manufacturing and CMO management
• Demonstrated leadership experience in a global, matrixed organization
• Proven track record in delivering operational performance and supply reliability
• Strong knowledge of GMP and regulatory expectations