Jobs · Analyst · Indiana

Director - Dissolution Science & Biopharmaceutics

Eli Lilly and Company · Indianapolis, IN · 3 wk ago
Analyst$149k–$257k/yrFull-time

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.

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