Are you passionate about the intricate world of small molecules? As a volunteer you will play a pivotal part in the development, formulation, manufacturing, quality control, and regulation of small molecule drug substances and various dosage forms.
Expertise in Small Molecules: You will need to be well-versed in various small molecule categories, including psychoactive, psychiatric, pulmonary, steroid, inhalation, aerosol agents, nonradioactive imaging agents, cardiovascular and analgesic products, over-the-counter medicines, and specialized medications for gastrointestinal, renal, endocrine, and ophthalmic conditions
.Method Development and Monographs: You will be involved in all facets of developing and revising small molecule methods or monographs and their associated reference standards. Small Molecules Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in various therapeutic categories
.
Who is U
SPThe 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 worldwid
e.
Who are our Expert Voluntee
rs?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 proce
ss.
Chair Responsibili
- tiesLeads, listens, and builds consensus among committee mem
- bersElects Expert Committee (EC) Members through their Council of Experts (CoE)
- roleChairs and leads a
- n ECEnforces standards of conduct as expressed in USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethi
- cs Participates in Collaborative Group discuss
- ionsLeads Chair succession planning and develops “next generation” of volunt
- eersServes as the face of th
- e ECAdministers the EC’s Work
- PlanReviews disclosure statements and manages conflicts of inte
- restPrepares 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 outc
- omesAdopts the Rules and Procedures of the 2025-2030 Council of Experts (CoE Ru
- les)Approves General Notices and General Chapter <11> USP Reference Stand
- ardsParticipates in the adjudication of app
- ealsRecommends the number and types of ECs for the next c
- ycleAppoints new/replacement EC Chairs through CoE
- roleConsiders long-term implications of activities on
- USPFulfills all duties of an EC Me
mber
Focus
AreaAntibiotic, Antiviral, and Antimicrobial Drug Substance and Drug Product Monogr
- aphs:This category focuses on creating and updating monographs related to antibiotics, antimicrobials, and antiviral drugs. It includes both drug substances and drug prod
- ucts.The committee works on converting microbial assays to high-performance liquid chromatography (HPLC) as
- says.They collaborate with other Small Molecules and Over-the-Counter (OTC) Expert Committees, the FDA, and stakeholders to address issues related to standard-setting for USP monogr
aphs.
Cough, Cold, and Analgesic Drug Substance and Drug Product Monog
- raphs:This category involves developing and revising monographs for cardiovascular drugs, cough and cold medications, and analg
esics.
Gastrointestinal, Renal, Endocrine, and Oncology Drug Substance and Drug Product Mono
- graphs:The committee focuses on gastrointestinal, renal, endocrine, and oncology drugs, both substances and pr
oducts.
Psychiatric, Psychoactive, Neuromuscular, Radiopharmaceuticals, and Imaging Drug Substance and Drug Product Mon
- ographs:This category covers psychiatric drugs, psychoactive substances, neuromuscular agents, radiopharmaceuticals, and imagin
- g drugs.Selected general chapters related to radiopharmaceuticals are also con
sidered.
Pulmonary, Aerosol, and Steroids Drug Substance and Drug Product Mo
- nographs:The committee works on monographs for pulmonary drugs, aerosols, and
steroids.
Cardiovascular, Ophthalmology, Otic, Dermatology, and Veterinary Drug Substance and Drug Product M
- onographs:This category includes cardiovascular drugs, ophthalmology medications, otic (ear-related) drugs, dermatology products, and veterinary
medicines.
Key I
ssues/GoalsAs a Small Molecules Volunteer, you will be at the forefront of advancing pharmaceutical standards. Your responsibilities include converting microbial assays to chromatography techniques (HPLC, GC, etc.). Additionally, you will collaborate closely with other Small Molecules Expert Committees, the FDA, and stakeholders to address issues related to the standard setting of USP monographs. Your commitment extends beyond standards—participate and contribute to global health initiatives through collaborative efforts with various organizations. Join us in shaping the future of small molecule th
erapeutics!
Required Qualifications (Techn
- ical Skills)Pharmaceutical Product Development of small molecules
- is crucial.Understanding spectroscopic techniques (such as UV-Vis, IR, NMR, MS, ICP) and chromatographic methods
- (HPLC, GC).Method Development: Ability to develop and validate analytical methods specific to small molecules. This includes optimizing parameters, ensuring sensitivity, and
- robustness.Mass Spectrometry (MS): Familiarity with mass spectrometry is essential. MS is used to identify and characterize small molecules, drugs, metabolites, and larger molecules like proteins a
- nd peptides.Chemoinformatics: Utilize computational tools for predicting properties, designing molecules, and virtua
- l screening.Expertise in Use of GC 81 (Microbial Assay for Potency): Proficient in conducting microbial assays for potency, specifically using USP General Chapter
- 81 (GC 81).Pharmacokinetics (PK): Understanding PK principles helps assess drug absorption, distribution, metabolism, an
- d excretion.Formulation Science: Knowledge of formulating small molecules into various d
- osage forms.Regulatory Compliance: Awareness of global regulatory guidelines related to small molecule
- development.Problem-Solving: Strong research skills for troubleshooting and addressing challenges during drug
development.
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 commo
- n objectives.Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among commi
- ttee members.Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's missi
- on 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 broad
- er community.Ability to represent the committee's interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and be
- st 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 rec
ommendations.
Volunteer Tim
- e Requirement Must 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
Trav
el 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 p
er 5-year cycle
