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Online Resumes with "Product Quality Support"
Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance
Ideal Companies: medical device companies; adjunct college professor; education manager within a company
Associated Scientist_ Protein formulation and drug product development 2017 - present Shire Provided formulation and process development support for two injectable monoclonal antibody drug product development programs. Designed executed and communicated results of formulation robustness study pH range study PS80 range study. * Executed and communicated results of stability and comparability studies including evaluation of d...