Biologics CMC Drug Product Director

Job Summary

A company is looking for an Associate Director, Biologics CMC Drug Product Development.

Key Responsibilities

• Develop biologics drug product formulations, processes, and administration/delivery methods throughout the program's lifecycle
• Manage biologics drug product process technical transfer to CMOs and oversee manufacturing
• Ensure compliance with FDA, cGMPs, and ICH guidelines while authoring technical documents and regulatory filings

Required Qualifications

• Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a relevant field
• Minimum 8+ years of experience in biotech/pharma, focusing on drug product development and manufacturing for therapeutic protein products
• Extensive hands-on experience in protein formulation development and fill-finish process engineering
• Proven ability to manage global external vendors for development, manufacturing, and testing
• Experience in generating CMC regulatory sections for IND, IMPD, BLA, and MAA filings