- Salary
- $200k – $250k/yr
- Location
- San Carlos, CA
- Workplace
- Onsite
- Type
- Full-time
- Department
- CMC
- Seniority
- Director
- Education
- PhD
- Source
- Lever
Description
Attovia Therapeutics, 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 supply of clinical products.
Skills
FDAComplianceSupply Chain ManagementTechnical Writing