Director of Drug Substance Development

Job Summary

A company is looking for an Associate Director, Process Development Drug Substance.

Key Responsibilities

• Lead the process development and cGMP manufacture of small molecule drug substances at CDMOs
• Oversee the development of robust manufacturing processes utilizing Quality by Design (QbD) principles
• Author and/or review drug substance sections of regulatory dossiers and technical reports

Required Qualifications, Training, and Education

• Bachelor's degree and PhD in Chemistry
• Strong record of achievement in drug substance development and manufacturing
• Substantial experience in drug development and manufacturing technologies
• Demonstrated technical expertise in chemical process development
• Proven project management skills for technical programs