Director - Dissolution Science & Biopharmaceutics

Role: Senior leader in dissolution science and biopharmaceutics within Lilly's Synthetic Molecule Design and Development (SMDD) organization, focusing on small molecule drug products from early development through commercialization. Responsibilities: develop and validate dissolution methods linking in vitro performance to in vivo behavior; build biopharmaceutics strategies using in vitro, in vivo, and in silico tools including PBBM; author and defend regulatory submissions and responses related to product performance; lead a small team of scientists, guiding technical and strategic initiatives; collaborate cross-functionally with formulation, analytical, engineering, clinical pharmacology, and regulatory teams; influence external scientific community through publications and conferences; evaluate emerging science for integration into practices. Requirements: Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, Chemical Engineering, or related field with 8+ years (or equivalent experience with MS/BSc); proven expertise in dissolution science, biopharmaceutics, and product performance for small molecules; experience authoring regulatory content and applying PBBM for biowaivers and risk assessments; knowledge of regulatory requirements (FDA, EMA). Preferred: strong publication record, proficiency with modeling platforms (e.g., GastroPlus, Simcyp), formulation development knowledge, and influence skills. High-value specifics: focus on small molecules, biopharmaceutics, early to late-stage development, regulatory submissions, biowaivers, IVIVC, and cross-functional leadership. Work setup: on-site in Indianapolis, with minimal travel (~0-10%).