Lee’s experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.
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