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Vice President, Pharmaceutical Development And External Manufacturing
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Full-time
- The drug development cycle is also much shorter and capital efficient than traditional modalities.
- Provide strategic, operational and research leadership to drive the pharmaceutical development and external manufacturing of a pipeline of innovative therapeutic and companion imaging agents.
- Lead and manage multiple and concurrent CMC development projects including process, formulation and analytical development.
- Mentor laboratory-based radiochemists and analytical chemists to ensure execution of rigorous CMC development programs leading to efficient tech transfer, robust products and methods, and successful regulatory submissions.
- Oversee and own drafting of CMC sections of regulatory submissions (e.g., INDs, CTAs, NDAs) and respond to any queries from regulatory authorities.
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