Who is USP
The U.S. Pharmacopeial Convention (USP) 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
.
Chair Responsibiliti
- esLeads, listens, and builds consensus among committee membe
- rsElects Expert Committee (EC) Members through their Council of Experts (CoE) ro
- leChairs and leads an
- ECEnforces standards of conduct as expressed in USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in Collaborative Group discussio
- nsLeads Chair succession planning and develops “next generation” of voluntee
- rsServes as the face of the
- ECAdministers the EC’s Work Pl
- anReviews disclosure statements and manages conflicts of intere
- stPrepares for meetings by working with USP staff to develop meeting agenda and briefing materials; manages meeting agenda, including meeting closure, facilitates EC meeting and discussion; and focuses on and summarizes outcom
- esAdopts the Rules and Procedures of the 2025-2030 Council of Experts (CoE Rule
- s)Approves General Notices and General Chapter <11> USP Reference Standar
- dsParticipates in the adjudication of appea
- lsRecommends the number and types of ECs for the next cyc
- leAppoints new/replacement EC Chairs through CoE ro
- leConsiders long-term implications of activities on U
- SPFulfills all duties of an EC Memb
er
Chair Qualificat
- ionProven track record of effective leadership within the pharmaceutical / food / dietary supplement & herbal medicines industry or related fields, demonstrating the ability to guide and inspire diverse teams towards achieving common objectiv
- es.Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among committee membe
- rs.Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's mission and goa
- ls.Commitment to upholding the highest standards of integrity, ethics, and professionalism, serving as a role model for ethical conduct and accountability within the committee and broader communi
- ty.Ability to represent the EC’s interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and best practic
- es.Capacity to effectively manage time and resources, ensuring the efficient operation of the committee and timely completion of assigned tasks and deliverabl
- es.Dedication to ongoing learning and professional development, staying abreast of relevant industry trends, regulatory requirements, and emerging technologies to inform the committee's work and recommendatio
ns.
Focus A
reasBotanical Dietary Supplements and Herbal Medic
inesDevelopment of quality standards for botanical dietary ingredients and supplements, and herbal medicine ingredients from the Americas, East Asia, South Asia, and possibly Africa. Adulteration and contamination of botanicals and phytochemicals. Types of ingredients may include plant parts, plant powders, plant extracts, fungi, algae and lichens; classes of compounds include a variety of natural product constituents, in particular cannabinoids, and complex macromolecules such as carbohydrates, procyanidins/condensed tannins. Contaminants analysis including methods and limits for aflatoxins, pesticide residues, and pyrrolizidine alkaloids. Dietary supplement dosage forms including tablets, capsules (hard-shell and soft gels), sachets, gummies, and their performance analysis such as dissolution and disintegrat
ion.
Non-Botanical Dietary Supple
mentsDevelopment of quality standards for non-botanical dietary ingredients and supplements. Application of modern analytical methods for compendial use, oxidative oils analysis. Types of ingredients include amino acids, carbohydrates (simple and complex), mineral salts and complexes, oils, fatty acids and other lipids, probiotics and live biotherapeutic products, dietary proteins, small molecules, vitamins and preparations, nanomaterials. Dietary supplement dosage forms including tablets, capsules (hard-shell and soft gels), gummies, Manufacturing, and formulation; Performance testing (dissolution, disintegration), and their performance analysis such as dissolution and disintegra
tion.
Dietary Supplements Admission Evaluation & La
belingEvaluation of safety-based on human data (clinical studies and adverse events), toxicological data (in vivo/animal studies and in vitro studies), and potential interactions for a variety of dietary ingredients including plants, plant extracts, probiotics, proteins, amino acids, oils, and others to determine their admissibility into the USP comp
endia.
Food Ingr
edientsDevelopment of standards of food ingredients for the Food Chemicals Codex (FCC). Adulteration and contamination issues in food ingredients (elemental impurities, residual solvents, pesticides, mycotoxins, microbial), especially those consumed by vulnerable populations. Development of standards and solutions for priority ingredients for special nutrition needs. Development of advanced methods/ guidelines that support standards for prioritized novel and emerging ingredients. Advocacy for our work and collaboration with FDA and other regulatory ag
encies.
Key Issu
es/GoalsBotanical Dietary Supplements and Herbal Medicines: botanical identification; adulteration and contamination; sampling; fungal and algal ingredients; botanical monograph modernization; cannabis and canna
binoids.
Non-botanical Dietary Supplements: implementation of advanced analytical methodologies in the pharmacopeia, development of standards for challenging ingredients, adulteration of ing
redients.
Dietary Supplements Admission Evaluation & Labeling: safety of ashwagandha and other safety signals that may arise; Revising the approach to conducting safety ev
aluations.
Food Ingredients: address adulteration and contamination issues in foods (elemental impurities, pesticides, mycotoxins, microbial) and create tools and other solutions (guidelines, etc.), to address emerging contaminant issues; develop standards (identification standards) and other solutions for key quality attributes for priority ingredients for special nutrition needs, such as ingredients used in infant formula; develop advanced methods/ guidelines that support prioritized innovative
ingredients
Required Qualifications
/ TechnicalThe successful candidate would benefit from expertise in the several foll
- owing areas:Method development/method optimization/metho
- d validationReference standar
- d evaluationP
- harmacognosy
- ChemometricsChromatography: Liquid (H/UPLC), Gas, Pl
- anar (HPTLC)Analytical Spectroscopy: IR/Raman, NMR/qNMR, flame/plasma, Light Scattering, UV-Vis,
- NIR, XRF/XRDTitrimetry: Potentiometric including ISE,
- Karl FischerMass
- SpectrometryQuali
- ty by DesignMultivariate/chemomet
- ric analysisW
- et chemistryDNA analysis,
- PCR methodsNomenclature
- and labelingPl
- ant taxonomyMicrobiolo
- gic analysisEnzyme acti
- vity methodsBiopolymer size and mass analysi
- s (SEC-MALS)Contamin
- ant analysisDetection of
- adulterationEvidence-based toxicolo
- gy reviewingIn silico toxi
- cology testsIntegrat
- ive medicineRegulatory ris
- k assessmentSurveillance/adverse effec
- t monitoringSpecial nutrition ingredients including dietary proteins, amino acids
- , HMO, etc.,Statistics background and experience with the design of
- experimentsUnderstanding of regulatory frameworks/programs for food
- ingredientsExperience with the testing of food ingredients for quality/
authenticity
Additional Desired Q
ualificationsBotanical Dietary Supplements and Herbal Medicines: practicing pharmacologists, pharmacognosists, herbalists
, naturopathsNon-Botanical Dietary Supplements: clinical or clinical pharmacolo
gy experienceDietary Supplements Admission Evaluation & Labeling: Clinical research experience utilizing herbal medicines and dietar
y supplementsFood Ingredients: experience in next-generation sequencing, NMR; expertise in botanical ingredient analysis, especially focusing on authenticity and
adulteration.
Volunteer Ti
- me RequirementMust be able to contribute average of 5 hours per week with
- some variationMeetings: 1 to 2 face-to-face official meetings p
- er fiscal yearTeleconferences held as needed for official meetings and wo
rking sessions
Tra
vel RequirementMust be able to attend two (2) in-person collaborative meeting at USP Headquarters in Maryland, US, Brazil, China, or India per fiscal year; minimum of 3 in-person attendance p
er 5-year cycle
