Director, Technical Operations (Biologics CMC Technical Writing)

The Director, Technical Operations (Biologics CMC Technical Writing) leads the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, including Biologics License Applications (BLA). This role involves developing and executing CMC submission strategies, authoring high-quality scientific content, and collaborating with cross-functional teams to ensure regulatory readiness. The position requires extensive experience in biologics development, manufacturing, and technical writing to support the commercialization of rare disease therapies.