I have both academic and extensive industrial experience in chemistry and pharmaceutical sciences covering all aspects of CMC (chemistry, manufacturing, and controls). I've been a Research Assistant Professor at the University of Arizona since 2002 where I lectured for the pharmaceutical chemistry and physical pharmacy course for the Pharm D program. I've been involved in both start-up novel small molecule pharmaceutical companies as well as mid-sized and large public biopharmaceutical companies. I've been directly responsible for the research and IND authoring of more than 16 IND submissions (to both CDER and CBER), IMPDs, and many successful grant applications totaling over $40MM. My experience covers a range of R&D as well as business and partnering activities. I've been on due diligence teams for several partnerships and two acquisitions. I direct the CMC efforts from discovery and in/out-licensing through commercial launch activities. My API experience covers the lifecycle from synthetic route scouting and medicinal chemistry, process chemistry, crystal form, salt and polymorph selection, analytical chemistry development and validation, cGMP production and release of API, to QbD and PPQ. My drug product experience includes pre-formulation, QSPR, formulation, tech transfer and cGMP manufacturing of both solid oral dosages as well as sterile, complex parenterals (including nanomedicines, lipid nanoparticles, and liposomes), topicals, and inhalation products. I've been responsible for the scaling of numerous synthetic routes from milligram med-chem scales through validated cGMP commercial processes at hundreds of kilos per batch. I've taken two products from discovery through Phase 3 international pivotal studies and one of those through commercial launch. Specialties: CMC, regulatory filings, synthetic route selection and process chem dev, tech transfer, due diligence, solid state characterization, pre-formulation and formulation, ADMET/PK background and relationship to physical-chemical properties, QSPR directed med-chem experience (quantitative structure properties relationships), IND eCTD submissions, project management, portfolio management, extensive experience with global contract manufacturing and research organization management