Associate Director, External Manufacturing Biologics Drug Substance Technical Lead

About the role

Our Large Molecule Technical Operations Unit is seeking a highly motivated Associate Director to support drug substance manufacture within our External Manufacturing Network. The role works with strategic external partners, provides technical leadership, and drives technical excellence in biologics manufacturing.

Key responsibilities

• Lead technical interface between internal technical operations and external partners, providing guidance and ensuring adherence to standards.
• Execute technical due‑diligence assessments, risk identification, and mitigation plans for external partners.
• Manage technical transfers, site readiness activities, and validation strategies for new and existing products.
• Support external partners in process optimization, issue resolution, and capacity improvement.
• Coordinate complex investigations and review partner change requests, deviations, and master batch record changes.

Required profile

• Bachelor’s degree in engineering, biological/chemical sciences or related discipline with at least 10 years of relevant manufacturing experience.
• Minimum of 5 years experience in drug substance manufacturing, leading technical transfers and commercial production.
• Strong communication, leadership, and ability to work across internal and external teams; willingness to travel 10‑20%.

Required skills

• Drug substance manufacturing
• Technical transfer
• Process development
• Validation
• Quality systems
• Root cause analysis
• Risk assessment
• Lean Manufacturing / Six Sigma
• Project management
• Regulatory compliance