Senior Scientist

Zoetis, Inc. Design bio predictive in vitro testing strategies (e.g., discriminating dissolution/release, permeation/IVRT/IVPT as applicable) to characterize product performance and support clinically relevant decision-making across dosage forms including sterile liquids, suspensions, and topicals. Develop, optimize, qualify, and validate in vitro methods that are fit-for-purpose, robust, and stability-indicating/discriminating to demonstrate performance equivalency across formulation variants, including changes in excipients, concentrations, microstructure, and critical material attributes. Build scientific frameworks to justify product performance comparability across manufacturing process differences (scaleup/ scale-down, mixing/shear/hold times, filtration, filling, and other unit operations), linking CQAs/CMAs/CPPs to in vitro outcomes. Establish in vitro--in vivo--relevance approaches where appropriate (e.g., IVIVR/IVIVC concepts, mechanistic risk assessments), translating biopharmaceutics understanding into clear comparability arguments. Plan and execute experimental designs (DoE) to identify critical drivers of performance, define proven acceptable ranges, and support control strategies for formulation and process. Analyze, model, and interpret performance datasets using statistical and mechanistic tools to build process/formulation understanding, troubleshoot variability, and resolve complex analytical/bio performance challenges. Lead hands-on laboratory execution: set up instruments and fixtures, run studies independently or within cross-functional teams, ensure data integrity, and maintain high-quality documentation. Drive implementation and adoption of bio performance methodologies from early development through bench/pilot to manufacturing scale, enabling efficient development, tech transfer, and lifecycle management. Author and review high-quality technical and regulatory documentation, including study protocols, method reports/validations, comparability assessments, presentations, memos, and sections for regulatory submissions. Coordinate with internal stakeholders (Formulation Development, Biopharmaceutics, Analytical Sciences, Manufacturing/Tech Ops, Quality, Regulatory) and external partners (CROs/CMOs) to ensure aligned strategy, timely execution, and successful delivery. Mentor and train colleagues in bio predictive in vitro methods, performance equivalency strategy, data interpretation, and best practices for compliant scientific documentation. PhD in Pharmaceutics/Pharmaceutical Sciences, Chemical Engineering, Chemistry (Analytical/Physical), Biomedical Engineering/Bioengineering, or related required. Telecommuting may be permitted. When not telecommuting, must report to worksite. Up to 15% mostly international travel for training and tech transfer. To apply, email your resume to [email protected] and reference job #10447598.