Who is USP The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP’s fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. Who are our Expert Volunteers? A hallmark of USP’s standards is that they are determined by independent scientific experts, USP Expert Volunteers are selected based on their individual expertise and experience and use their best personal, professional, and scientific judgment to work collaboratively on setting standards, USP Expert Volunteers must agree to disclose conflicts of interest and to uphold standards of conduct that preserve the integrity of the standard setting process. Focus Area • Revise and modernize USP <665> and associated informational chapter <1665> to align with evolving global regulatory expectations, including ICH Q3E, and to support risk-based evaluation of plastic manufacturing components and single-use systems using current manufacturing, materials, and analytical science.. 2025-2030 KEY ISSUES • Resolve stakeholder comments and inquiries related to <665> and <1665>. • Update extractables guidance using risk-based approaches, including low-risk testing scenarios and appropriate extraction strategies. • Ensure alignment across <665>, <1665>, stakeholder feedback, and emerging ICH Q3E guidance to support global harmonization. How will YOU create impact here at USP? In this role as a USP Volunteer, you contribute to USP’s public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. Required Expertise • Single-Use System (SUS) suppliers • Extractables and Leachables (E&L) • Pharmaceutical and biopharmaceutical manufacturing • Risk assessment and toxicology • Single-use and disposable technologies Additional Desired Preferences • · Practical experience with plastic manufacturing components and single-use systems • · Risk-based E&L testing expertise · Knowledge of global regulatory expectations (e.g., ICH Q3E) • · Experience spanning materials science, analytical chemistry, toxicology, and manufacturing • · Background in standards development or regulatory science