Advisor Dissolution Science & Biopharmaceutics — SMDD

About the role

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs advances small molecules, peptides, and oligonucleotides from early discovery through commercialization. Our scientists and engineers develop innovative technical solutions across a broad portfolio of projects, applying deep technical expertise to accelerate overall drug development and bring the next generation of life-changing medicines to patients.

Responsibilities

• Dissolution Method Development
• Develop and optimize dissolution methods for oral solid dosage forms (immediate-release and modified-release) that detect meaningful changes in critical quality attributes while performing reliably across analysts, instruments, and sites.
• Justify the discriminating nature of proposed methods through systematic studies linking method parameters to formulation and process variables, generating data packages that withstand regulatory scrutiny.
• Support the dissolution method lifecycle, including validation, method transfers, and troubleshooting.
• Develop and justify phase-appropriate dissolution specifications, including clinically relevant acceptance criteria.
• Biopharmaceutics Modeling & In Vivo Prediction
• Build, parameterize, and validate PBPK/PBBM models to predict oral absorption, assess formulation bridging risk, and establish the clinical relevance of dissolution methods and specifications.
• Design and execute biorelevant dissolution and solubility experiments that generate input data for mechanistic absorption models.
• Support biowaiver justifications, in vitro-in vivo correlation/relationship (IVIVC/IVIVR) dossiers, and bioequivalence safe space assessments using integrated in vitro and in silico data.
• Drug-Product Performance & Regulatory Interface
• Partner with formulation scientists to guide formulation selection and process decisions based on dissolution testing results and model predictions.
• Author and defend dissolution and biopharmaceutics content in regulatory submissions and responses to health authority questions.
• Collaborate with clinical pharmacology and regulatory colleagues to align dissolution and biopharmaceutics strategies with clinical development plans and post-approval lifecycle management.
• Represent product performance on multidisciplinary project teams.
• External Engagement & Growth
• Engage the external scientific community through publications, conference presentations, and collaborations in dissolution science and biopharmaceutics.
• Stay current with evolving regulatory expectations for dissolution methods, modeling approaches, and product performance control strategies.

Requirements

• Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 0-5 years of directly relevant experience in dissolution method development and/or biopharmaceutics;
• M.S. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 5+ years of directly relevant experience in dissolution method development and/or biopharmaceutics;
• B.S. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 8+ years of directly relevant experience in dissolution method development and/or biopharmaceutics.

Additional Skills & Preferences

• Experience with PBPK/PBBM platforms (e.g., GastroPlus, Simcyp, DDDPlus, SIVA) and their application to clinically relevant dissolution method development, specification setting, or in vivo performance assessment.
• Experience designing dissolution methods and planning for the full method lifecycle.
• Knowledge of regulatory expectations for dissolution method development and justification, for worldwide marketing authorizations.
• Proficiency with scripting languages (R, Python, or MATLAB) for data analysis, model parameterization, or automated reporting.
• Strong scientific writing skills and external publication record.

Qualifications

• Work experience in pharmaceutical sciences, analytical chemistry, physical chemistry, or chemical engineering.
• Experience in dissolution method development and/or biopharmaceutics.
• Knowledge of physicochemical characterization techniques relevant to oral drug product performance (e.g., dissolution, solubility, permeability, particle size, solid-state characterization, HPLC, UV/Vis).

Skills

• Ability to develop and justify dissolution methods and specifications.
• Expertise in building and validating PBPK/PBBM models.
• Experience in designing and executing biorelevant dissolution and solubility experiments.
• Collaboration with clinical pharmacology and regulatory colleagues.
• Proficiency in scientific writing and external publication.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $126,000 - $204,600

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).