Responsibilities include supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) as well as manufacturing technology transfer to commercial sites. * Lead manufacturing technology transfer activities, primarily to Daiichi Sankyo Europe and CDMOs in the EU, as well as pivotal formulation development. * In-depth knowledge of global CMC development, particularly formulation research, technology transfer, CMC regulatory requirements, and GMP compliance.
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