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We are looking for a CMC Director to oversee the chemistry, manufacturing, and controls of a compound for late phase clinical trials.
This position provides a phenomenal opportunity for a talented individual who seeks exposure and participation across all dimensions of a very well-positioned biotechnology company's growth.
Evaluate and select API and drug product CMOs.
Be the primary liaison with CMOs. Manage and monitor CMOs for tech transfer and development of new and existing API and drug product. Scale-up, manufacturing, and packaging for phase III clinical trial products
CMO Quality (QA) and Regulatory assurance (RA)
Support CMOs during the development and validation phases of projects
Preparation and submission of CMC sections of IND and NDA, including responses to questions from FDA.
Maintain awareness and act as expert on regulatory CMC requirements.