狠狠撸

San Francisco Bay Area United States

Senior Director of Pharmaceutics, Plexxikon Inc. (Member of Daiichi-Sankyo Group)

Medical / Health Care / Pharmaceuticals

Pharmaceutics subject matter expert: >15 years experience in drug product development, preclinical (PK, pharmacology, efficacy, toxicology), polymorph/salt screen, QbD-based formulation development, process selection (direct compression, roller compaction, granulation, spray-dried dispersion, hot-melt extrusion) scale-up, validation, regulatory submissions, extensive experience in CMO selection and management, budgeting, staff hiring and development. Projects delivered: - Cotellic (Cobimetinib): QbD-based formulation development FIH-Phase III (Formulation Patent, NDA) - Seroquel (Quetiapine): Developed new formulations, authored DP reports and CMC modules (NDA) - Crestor (Rosuvastatin): A...