Director - Dissolution Science & Biopharmaceutics

Core Technical Scope

• Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug product performance to in vivo behavior, spanning immediate-release and modified-release oral solid dosage forms.
• Apply conventional and biorelevant/predictive dissolution as well as novel approaches to assess oral performance of drug molecules and formulations in humans.
• Build and execute biopharmaceutics strategies using in vitro, in vivo, and in silico tools — including physiologically based biopharmaceutics modeling (PBBM) — to assess oral absorption, predict bridging risk, and establish clinically relevant specifications.
• Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR dossiers.

Strategic and Cross-Functional Leadership

• Partner with formulation scientists, analytical chemists, engineers, clinical pharmacologists, and regulatory colleagues to define product performance control strategies — including specifications, dissolution method lifecycle management, and post-approval change strategies.
• Support the design of new dosage forms and drug delivery technologies by applying pharmaceutical sciences knowledge spanning formulation, biopharmaceutics, pharmacokinetics, and patient-centered drug product design.
• Plan and lead short-term and long-term dissolution and biopharmaceutics development activities across assigned programs and broader portfolio.
• Develop technical agendas and timelines, recommend resource allocation, communicate progress, and propose changes in direction when warranted.

People Leadership and External Engagement

• Directly lead a small team (1–5 scientists), providing technical mentorship, career development, and performance coaching.
• Influence and engage the external scientific community through publications, conference presentations, and collaborations that advance Lilly’s dissolution science and biopharmaceutics capabilities.
• Evaluate and integrate emerging science from adjacent disciplines (e.g., formulation science, PAT, modeling and simulation) into dissolution and biopharmaceutics practice.