Associate Director, Drug Substance

The Opportunity:

This is a highly visible leadership opportunity to join an attractive discovery-based company that has diverse early and potential late-stage pipeline of drug candidates. In this role you will provide leadership in development and execution of robust and cost-effective processes for new small molecule APIs.

Your Role:

• Manage all late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites.
• Ensure regulatory compliance at vendor site.
• Lead all late-stage drug substance development efforts toward the commercialization of the small molecule drug candidates.
• Display the leadership and technical skills necessary to lead the development and manufacturing activities at CRO/CMO sites with minimal supervision. 
• Identify and develop in- process controls for potential commercial process validation. Act as the key technical transfer resource, in implementation of optimized processes on manufacturing scale. Trouble shoot and conduct problem solving of  scale-up and manufacturing issues.
• Review and approve specifications, batch records and other critical documents.
• Work with other process chemists to support early-stage manufacturing process development/manufacturing and move the project to late-stage developme