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Director, Continuous Process Development
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Full-time
- Alexion’s Product Development and Clinical Supply (PDCS) organization is seeking an expert synthetic organic chemist to lead our strategic capability build in drug substance continuous processing, for deployment across an emerging small molecule portfolio.
- Building an innovation ecosystem for development and deployment of advanced manufacturing technologies for Alexion synthetic modalities.
- Providing technical expertise to enable authoring of drug substance modules for regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.
- Partnering with Alexion technical experts to formulate integrated and complete CMC control strategies for NDA/MAA.
- Deep understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
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