USP Small Molecules - Member

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 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.

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

Focus Area

Antibiotic, Antiviral, and Antimicrobial Drug Substance and Drug Product Monographs:

• This category focuses on creating and updating monographs related to antibiotics, antimicrobials, and antiviral drugs. It includes both drug substances and drug products.
• The committee works on converting microbial assays to high-performance liquid chromatography (HPLC) assays.
• 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 monographs.

Cough, Cold, and Analgesic Drug Substance and Drug Product Monographs:

• This category involves developing and revising monographs for cardiovascular drugs, cough and cold medications, and analgesics.

Gastrointestinal, Renal, Endocrine, and Oncology Drug Substance and Drug Product Monographs:

• The committee focuses on gastrointestinal, renal, endocrine, and oncology drugs, both substances and products.

Psychiatric, Psychoactive, Neuromuscular, Radiopharmaceuticals, and Imaging Drug Substance and Drug Product Monographs:

• This category covers psychiatric drugs, psychoactive substances, neuromuscular agents, radiopharmaceuticals, and imaging drugs.
• Selected general chapters related to radiopharmaceuticals are also considered.

Pulmonary, Aerosol, and Steroids Drug Substance and Drug Product Monographs:

• The committee works on monographs for pulmonary drugs, aerosols, and steroids.

Cardiovascular, Ophthalmology, Otic, Dermatology, and Veterinary Drug Substance and Drug Product Monographs:

• This category includes cardiovascular drugs, ophthalmology medications, otic (ear-related) drugs, dermatology products, and veterinary medicines.

Key Issues/Goals

As 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 therapeutics!

Required Qualifications (Technical 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 and peptides.
• Chemoinformatics: Utilize computational tools for predicting properties, designing molecules, and virtual 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, and excretion.
• Formulation Science: Knowledge of formulating small molecules into various dosage 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.

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 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

Language Proficiency

While USP operates primarily in English, our Expert Volunteers come from all over the world and speak multiple languages. While most LIVE business meetings are conducted in English, much of the work for the Expert Scientist includes reading, reviewing, and writing in Technical English. Proficiency in written English is required. Effective verbal communication may be facilitated by technology and written pre-read materials. Encourage application even if English is not the native spoken language but are proficient in reading and writing in Technical English. For more information on English Proficiency requirements, please refer to this link.