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 • The Expert Panel will prioritize the evaluation and implementation of scientifically robust, regulatory-compliant alternatives to the Rabbit Pyrogen Test. The main focus will be on advancing in vitro methods such as the Monocyte Activation Test (MAT), developing new and revised documentary standards, and supporting the transition toward non-animal testing strategies. The panel will also facilitate the creation of physical material standards to enable broad adoption of these modern approaches. 2025-2030 KEY ISSUES Key issues for this period include supporting the global phase-out of animal-based pyrogen tests, developing validated reference standards for non-endotoxin pyrogens, and establishing clear guidance and acceptance criteria for alternative methods. The panel will also address the need for harmonization with international standards and ensure that new methods are applicable across diverse product classes and regulatory environments. Member Responsibilities • Explores specific compendial topic(s) and produces the deliverable(s) identified in the Expert Panel charge within a specific time frame • Performs assigned tasks and provides recommendations to the sponsoring Expert Body/Bodies • Provides final advisory recommendations in writing to the sponsoring Expert Body/Bodies • Strives to reach agreement with other members on compendial topics, although achieving unanimous agreement is not required • Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.) • Notifies USP staff of conflicts of interest; keeps disclosures up to date • A conflict of interest does not limit participation in discussions or the making of recommendations, provided the Expert Panel Member has disclosed this conflict. However, an Expert Committee Member who joins an Expert Panel is held to the move stringent conflict of interest requirements and Standards of Conduct applicable to an Expert Committee Member. • Develops and maintains awareness of fellow volunteers’ conflict of interest to help facilitate conflict of interest management • Disposes of any confidential materials at the conclusion of service 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 Panel members should have deep expertise in pyrogen detection methods, including both traditional (e.g., RPT, LAL) and modern in vitro assays like MAT and PBMC-based tests. Additional required skills include regulatory science, method validation, and experience with the development and application of reference standards for biological assays. Additional Desired Preferences Preferred expertise includes a strong background in immunology and cytokine biology, particularly in cytokine signaling and assay development, as well as experience with non-endotoxin pyrogen detection. Familiarity with international harmonization efforts and a proven ability to collaborate with regulators, industry, and scientific organizations to drive adoption of new methods are also highly valued.