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 foods, medicines and dietary supplements worldwide. USP is committed to adopting more environmentally sustainable quality testing practices, manufacturing technologies, and health care actions across the pharmaceutical lifecycle.
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. USP Expert Volunteers work under a policy to foster a more sustainable environment, creating and revising standards toward reduction of energy consumption, minimization of toxic waste, reduction of animal testing, and water conservation.
Member Responsibilities
- Reads and abides by USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.) and notifies USP staff of conflicts of interest
- Approves USP standards through balloting and voting (USP–NF, Reference Standards)
- Commits to understanding of USP’s Mission
- Advocates for and represents USP and its future
- Handles confidential information properly
- Considers regulatory framework
- Challenges constructively
- Commits time and effort to participate in EC activities
- Disposes of any confidential materials at the conclusion of service
- Adheres to the policy of developing and updating more environmentally friendly standards
Focus Areas
Botanical Dietary Supplements and Herbal Medicines
Development 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 disintegration. This includes developing and updating USP standards to develop fit-for purpose methods using environmentally friendly methodology and state of the art analytical technologies where practical.
Non-Botanical Dietary Supplements
Development 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 disintegration. This includes developing and updating USP standards to develop fit-for purpose methods using environmentally friendly methodology and state of the art analytical technologies where practical.
Dietary Supplements Admission Evaluation & Labeling
Evaluation 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 compendia.
Food Ingredients
Development 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 agencies. This includes Developing and updating USP standards to develop fit-for purpose methods using environmentally friendly methodology and state of the art analytical technologies where practical.
Key Issues/Goals
Botanical Dietary Supplements and Herbal Medicines: botanical identification; adulteration and contamination; sampling; fungal and algal ingredients; botanical monograph modernization; cannabis and cannabinoids.
Non-botanical Dietary Supplements: implementation of advanced analytical methodologies in the pharmacopeia, development of standards for challenging ingredients, adulteration of ingredients.
Dietary Supplements Admission Evaluation & Labeling: safety of ashwagandha and other safety signals that may arise; Revising the approach to conducting safety evaluations.
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 / Technical
- The successful candidate would benefit from expertise in the several following areas:
- Method development/method optimization/method validation
- Reference standard evaluation
- Pharmacognosy
- Chemometrics
- Chromatography: Liquid (H/UPLC), Gas, Planar (HPTLC)
- Analytical Spectroscopy: IR/Raman, NMR/qNMR, flame/plasma, Light Scattering, UV-Vis, NIR, XRF/XRD
- Titrimetry: Potentiometric including ISE, Karl Fischer
- Mass Spectrometry
- Quality by Design
- Multivariate/chemometric analysis
- Wet chemistry
- DNA analysis, PCR methods
- Nomenclature and labeling
- Plant taxonomy
- Microbiologic analysis
- Enzyme activity methods
- Biopolymer size and mass analysis (SEC-MALS)
- Contaminant analysis
- Detection of adulteration
- Evidence-based toxicology reviewing
- In silico toxicology tests
- Integrative medicine
- Regulatory risk assessment
- Surveillance/adverse effect monitoring
- Special nutrition ingredients including dietary proteins, amino acids, HMO, etc.,
- Statistics background and experience with the design of experiments
- Experience with the testing of food ingredients for quality/authenticity
Required Qualifications / Soft Skills
- Proven 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 objectives.
- Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among committee members.
- Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's mission and goals.
- 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 community.
- Ability to represent the committee's interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and best practices.
- Capacity to effectively manage time and resources, ensuring the efficient operation of the committee and timely completion of assigned tasks and deliverables.
- 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 recommendations.
Additional Desired Qualifications
- Botanical Dietary Supplements and Herbal Medicines: practicing pharmacologists, pharmacognosists, herbalists, naturopaths
- Non-Botanical Dietary Supplements: clinical or clinical pharmacology experience
- Dietary Supplements Admission Evaluation & Labeling: Clinical research experience utilizing herbal medicines and dietary supplements
- Food Ingredients: experience in next-generation sequencing, NMR; expertise in botanical ingredient analysis, especially focusing on authenticity and adulteration.
Volunteer Time Requirement
- Must be able to contribute average of 3.5 hours per week with some variation
- Meetings: 1 to 2 face-to-face official meetings per fiscal year
- Teleconferences held as needed for official meetings and working sessions
Travel Requirement
Must 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 per 5-year cycle
