About this role
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.
2025-2030 Focus Area:
• Revise and update the USP-NF General Chapters ⟨736⟩ Mass Spectrometry and ⟨1736⟩ Applications of Mass Spectrometry to incorporate the advancements in the field as pertaining to the application for the pharmaceutical systems in research and development, and drug product quality.
• Evaluate current methodologies, incorporate recent technological advances, and establish updated criteria based on the lifecycle approach model for instrument qualification and method validation to ensure alignment with ICH Q2(R2) and Q14, and industry's best practices.
2025-2030 KEY ISSUES
• Revision and update of USP-NF General Chapters ⟨736⟩ Mass Spectrometry and ⟨1736⟩ Applications of Mass Spectrometry.
• Inclusion of the new mass spectrometry techniques and modalities added in the last 10-15 years to the analytical toolbox of pharmaceutical systems quality and development, such as such as Ion Mobility Mass Spectrometry etc., and applications in biologics systems, including novel glycomics and glycoform profiling, characterization of uncommon post translational modifications, and characterization of proteins.
• Development of clearer, practical guidance regarding Mass Spectrometer instruments qualification base on Analytical Instrument and System Lifecycle approach.
Required Expertise:
Advanced practicing MS scientists active in the applications of MS in pharmaceutical and or biopharmaceutical drug product development and quality, with expertise in at least one of the following applications.
• Expertise in small molecules mass spectrometry such as assay, impurity profiles and quantitation, mutagenic impurities (including nitrosamines), structure elucidation.
• Expertise in mass spectrometry applications for biologics, including therapeutic product development, characterization, manufacturing support, and quality control.
• Expertise in characterization and quality control of dietary supplements using mass spectrometry.
• Expertise in characterization and quality control of excipients.
• Expertise in assessment and characterization of microbial contamination in pharmaceutical systems.
Preferred Expertise:
• Practical experience conducting mass spectrometry analysis and/or interpretation of mass spectrometry results.
• Experience in applications of mass spectrometry in pharmaceutical, biotech, or healthcare environments.
• Knowledge of GLP requirements and guidelines (e.g., FDA, EMA, ISO, ICH standards) as pertain to pharmaceutical and biopharmaceutical products.
• Experience with and/or contribution to the development of pharmaceuticals and biopharmaceuticals public standards, guidance documents, or industry best practices (USP, ISO, ISPE, PDA, etc.)
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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.