Lead a team of analysts supporting a large volume (metric ton) scale-up of drug substance manufacture resulting in early release of clinical supplies for PIII studiesDesigned and executed a DOE to study the effects of minor changes in manufacturing resulting in the identification of key factors associated with variation in the stability of a PIII drug substance, allowing consistent manufacture of a more stable APIDeveloped methods and specifications for raw materials, in-process controls, and drug substance testing. Transferred methods to manufacturing facilities resulting in successful launch campaign and commercializationContributed to drug substance sections of regulatory filings (CTD, NADA), providing rapid response to regulatory queries resulting in regulatory acceptance of applicationsProvided analytical oversight of contract manufacturers, assessing deviations and directing experiments to ensure acceptable quality of purchased materialsReceived two performance awards (2011)

Various duties including manufacture of API, Quality Control laboratory technician, manufacturing site environmental testing, forensics testing of suspected counterfeit products, inspection of contracted facilities, support for regulatory pre-approval inspections, development of test methods and specifications for raw materials and intermediates used in the manufacture of API