Advisor Dissolution Science & Biopharmaceutics — SMDD

Position Overview

We are looking for a scientist who can combine deep understanding of dissolution science with biopharmaceutics modeling capability to enable robust control strategies for new products. You will develop dissolution methods suitable for worldwide regulatory submissions, robust enough to operate in a quality control environment, and relevant to clinical performance. You will also design and conduct biorelevant dissolution experiments to generate input data for biopharmaceutics risk assessments and physiologically based pharmacokinetic/biopharmaceutics (PBPK/PBBM) models, connecting invitro performance to invivo prediction.

• Dissolution Method Development
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  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
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  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, invitro‑invivo correlation/relationship dossiers, and bioequivalence safe space assessments using integrated invitro and insilico data.
• Drug‑Product Performance & Regulatory Interface
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  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
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  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.

• 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; orM.S. in the same fields with 5+ years of directly relevant experience; orB.S. in the same fields with 8+ years of directly relevant experience.
• Working knowledge of physicochemical characterization techniques relevant to oral drug product performance, such as dissolution, solubility, permeability, particle size, solid‑state characterization, HPLC, and UV/Vis.

• Experience with PBPK/PBBM platforms (e.g., Gastro Plus, Simcyp, DDDPlus, SIVA) and their application to clinically relevant dissolution method development, specification setting, or invivo 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.

Travel: 0–10%

Location:

LTCN, Indianapolis IN

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