Director of CMC Drug Substance

A company is looking for a Director, CMC Drug Substance (Remote).

Key Responsibilities

Direct CMC drug substance development and manufacturing activities across multiple projects

Lead strategy, planning, execution, and progress reporting for development and commercial products

Manage relationships with external partners and ensure compliance with health, safety, and quality regulations

Required Qualifications

Bachelor's degree with 15 years, Master's degree with 12 years, or PhD with 8 years of experience

Ph.D. in organic chemistry or chemical engineering preferred, with significant experience in the pharmaceutical / biotech industry

In-depth knowledge of synthetic route development and large-scale manufacturing processes

Experience with cGLP / cGMP requirements and regulatory guidelines

Direct experience in authoring drug substance sections for regulatory submissions