Director, CMC Management

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San Carlos, CA Full-time$200k–$250k / year Posted 30+ days ago

Above market. This role pays above the $189k median for similar USD roles (116 comparable postings in our corpus).

The company, Inc., is seeking a Director of CMC management to lead CMC regulatory strategy, submissions, and support the activities of our external CDMO for our biologics pipeline. Reporting to the Head of CMC, this role is responsible for preparation of CMC regulatory filings, providing technical guidance to CDMO on drug substance and drug product development and manufacturing, and ensuring CMC compliance with all applicable regulations. This role partners closely with Quality, Portfolio management, and Regulatory Affairs teams to ensure timely delivery of CMC regulatory sections and timely…

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