Advisor Dissolution Science & Biopharmaceutics — SMDD
Eli Lilly and Company
June 25, 2026
On-site
Indianapolis, IN
Clinical Research and Development
Responsibilities:
- Develop and optimize dissolution methods for oral solid dosage forms (immediate-release and modified-release) that reliably detect changes in critical quality attributes across analysts, instruments, and sites.
- Justify discriminating method performance through systematic studies linking method parameters to formulation and process variables.
- Support dissolution method lifecycle activities including validation, method transfers, and troubleshooting.
- Develop and justify phase-appropriate dissolution specifications and clinically relevant acceptance criteria.
- Build, parameterize, and validate PBPK/PBBM models to predict oral absorption, assess formulation bridging risk, and support clinical relevance of dissolution methods/specifications.
- Design and execute biorelevant dissolution and solubility experiments to generate input data for mechanistic absorption models.
- Support biowaiver justifications, IVIVC/IVIVR dossiers, and bioequivalence safe-space assessments using integrated in vitro and in silico data.
- Partner with formulation scientists; author/defend dissolution and biopharmaceutics content in regulatory submissions.
- Collaborate with clinical pharmacology and regulatory teams to align strategies with clinical development and post-approval lifecycle.
- Engage externally via publications and conference presentations; stay current with regulatory expectations.
Minimum Requirements:
- Ph.D. (0–5 yrs) or M.S. (5+ yrs) or B.S. (8+ yrs) in Pharmaceutical Sciences, Analytical/Physical Chemistry, or Chemical Engineering; experience in dissolution method development and/or biopharmaceutics.
- Working knowledge of physicochemical characterization techniques for oral drug performance (e.g., dissolution, solubility, permeability, particle size, solid-state, HPLC, UV/Vis).
Additional Skills/Preferences:
- Experience with PBPK/PBBM platforms (GastroPlus, Simcyp, DDDPlus, SIVA).
- Scripting proficiency (R/Python/MATLAB) for data analysis/reporting.
Location & Travel:
- Indianapolis, IN; travel 0–10%.
- Develop and optimize dissolution methods for oral solid dosage forms (immediate-release and modified-release) that reliably detect changes in critical quality attributes across analysts, instruments, and sites.
- Justify discriminating method performance through systematic studies linking method parameters to formulation and process variables.
- Support dissolution method lifecycle activities including validation, method transfers, and troubleshooting.
- Develop and justify phase-appropriate dissolution specifications and clinically relevant acceptance criteria.
- Build, parameterize, and validate PBPK/PBBM models to predict oral absorption, assess formulation bridging risk, and support clinical relevance of dissolution methods/specifications.
- Design and execute biorelevant dissolution and solubility experiments to generate input data for mechanistic absorption models.
- Support biowaiver justifications, IVIVC/IVIVR dossiers, and bioequivalence safe-space assessments using integrated in vitro and in silico data.
- Partner with formulation scientists; author/defend dissolution and biopharmaceutics content in regulatory submissions.
- Collaborate with clinical pharmacology and regulatory teams to align strategies with clinical development and post-approval lifecycle.
- Engage externally via publications and conference presentations; stay current with regulatory expectations.
Minimum Requirements:
- Ph.D. (0–5 yrs) or M.S. (5+ yrs) or B.S. (8+ yrs) in Pharmaceutical Sciences, Analytical/Physical Chemistry, or Chemical Engineering; experience in dissolution method development and/or biopharmaceutics.
- Working knowledge of physicochemical characterization techniques for oral drug performance (e.g., dissolution, solubility, permeability, particle size, solid-state, HPLC, UV/Vis).
Additional Skills/Preferences:
- Experience with PBPK/PBBM platforms (GastroPlus, Simcyp, DDDPlus, SIVA).
- Scripting proficiency (R/Python/MATLAB) for data analysis/reporting.
Location & Travel:
- Indianapolis, IN; travel 0–10%.