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Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial...
Lead global regulatory operations to achieve excellence in compliance and quality across all global projects, staying ahead with up-to-date knowledge on FDA, GCP, and ICH...
Play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and...