Experienced in formulation design and process development for solid oral dosage forms from discovery through commercial launch, including authoring of various regulatory documents.- Development of phase-appropriate solid oral dosage forms and manufacturing processes across all stages of development, including first-in-human and Phase 3/commercial.- Management of development and clinical manufacturing activities at contract manufacturing organizations (CMOs), including oversight of manufacturing, scale-up, and process transfers.- Development and optimization of spray drying, dry granulation, tablet compression, and film-coating unit operations including the use of Design of Experiments (DOE).- Authoring of relevant portions of regulatory documents, including the CMC sections of NDA, IND, and IMPD filings and responding to requests for information from various regulatory agencies.- Characterization of drug substance properties including: solubility, pKa, physical form screening, chemical stability, physical stability, solid state characterization (including SSNMR, DSC, TGA, PXRD, Raman, DVS, PLM).- Formulation of compounds for discovery and lead optimization, including intravenous, oral, subcutaneous, and intraperitoneal delivery to support pharmacokinetic, efficacy, and toxicity studies.- Characterization and quantification of solid state forms in pure drug substance and within formulations by various techniques including SSNMR (including 13C and 19F), DSC, PXRD, and Raman.