Associate Director, Drug Substance Development

Job Summary

A company is looking for an Associate Director, Drug Substance Development (Home Based / Remote) for a 12-month fixed-term contract.

Key Responsibilities

• Lead process development and cGMP manufacture of small molecule drug substances at CDMOs
• Ensure adequate supply of drug substance for clinical studies and other needs
• Author and/or review drug substance sections of regulatory dossiers and technical reports

Required Qualifications, Training, and Education

• Bachelor's degree and a Master's or PhD in Chemistry
• Over ten years of experience in drug development and manufacturing technologies, specifically in drug substance chemical process development
• Demonstrated technical expertise in chemical process development and new product introduction
• Experience with CMC regulatory requirements for pharmaceutical products
• Proven project management skills for technical programs