Director CMC Drug Substance - Atlanta Georgia

Company: VirtualVocations
Location: Atlanta, Georgia
Posted On: 01/29/2025

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



Key Responsibilities

Direct CMC drug substance development and manufacturing activities, providing scientific and technical leadership
Lead strategy, planning, execution, and progress reporting for development projects and commercial products
Identify and manage relationships with external partners, ensuring compliance with health, safety, environmental, and quality requirements


Required Qualifications

Bachelor's degree with 15 years, Master's degree with 12 years, or PhD with 8 years of relevant experience
Ph.D. in organic chemistry or chemical engineering preferred, with at least 7 years of related technical experience in the pharmaceutical/biotech industry
In-depth knowledge of synthetic route development, process optimization, and large-scale manufacturing of drug substances
Experience with cGLP/cGMP requirements and authoring drug substance sections of regulatory submissions
Proven director-level management experience with a focus on strategy development and team leadership More...

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