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 AREA - Therapeutic Peptides, Oligonucleotides and Complex Carbohydra
tes2025-2030 F
OCUSStandards to support complex drug substances and products in the peptide, oligonucleotide, and complex carbohydrate modalities. This includes developing new and revising current general chapters, monographs, and references standards to support all three modalities. Standards to support the analysis of raw materials used in production of drug substances/produ
cts.
2025-2030 KEY I
- SSUESDevelopment of the first monograph to support oligonucleotide therapeu
- tics.Standards to support species analysis for heparin prod
- ucts.Revisions of monographs for recombinant peptides to address new synthetic prod
ucts.
REQUIRED EXP
ERTISEUnderstanding of the characterization, analytical and/or bioassays, of one or more of the 3 modalities (oligonucleotides, peptides, or complex carbohydrates). The expert volunteer should have experience in one or more of the following areas for one or more of these modal
- ities:Setting specifica
- tions,Manufacturing processes and quality contro
- l, andMethods development and valid
ation.
PREFERRED EX
PERTISEThe expert volunteer should have experience in one or more of the following areas for one or more of these moda
- lities:Setting specific
- ations,Manufacturing processes and quality c
- ontrol,Formulation developme
- nt, andMethods development and vali
- dation.Characterizing synthetic and/or recombinant therapeutic peptides and methods to monitor impu
- rities.Microbial and HPLC-based assay methods, methods to monitor control impuriti
- es, andModernizing release m
- ethods.Understanding of USP revision p
- rocess.Understanding of the US and international regulations for one or more of these 3 moda
lities.
FOCUS AREA - Therapeutic
Proteins2025-20
30 FOCUSStandards to support protein therapeutics, including Insulins, enzymes, and monoclonal antibodies. This includes developing new and revising current general chapters and developing references standards to support protein therapeutics. Standards for new analytical technologies. Developing standards to broadly support different protein therapeutic classes, for example monoclonal ant
ibodies.
2025-2030 K
- EY ISSUESDeveloping documentary and physical standards to support binding and bioassays for protein ther
- apeutics.Developing documentary and physical standards to support new analytical technologies for protein characte
rization.
REQUIRED
EXPERTISEThe expert volunteer should have experience in one or more of the follow
- ing areas:Analytical characterization of protein therapeutics, bioassay de
- velopment,Manufacturing processes and qualit
- y control,Methods development, and v
- alidation.Experience with characterization or production of one or more of the following product types of Insulins, enzymes, and monoclonal a
ntibodies.
PREFERRE
D EXPERTISEThe expert volunteer should have experience in one or more of the follo
- wing areas:Formulation d
- evelopment,Methods to monitor control
- impurities.Understanding of USP revisi
- on process.Understanding of the US and international regulations for protein th
erapeutics.
FOCUS ARE
A - Vaccines202
5-2030 FOCUSStandards and guidelines to support vaccines, including mRNA, vial vectored, glycoconjugate, protein subunit, inactivated, attenuated, etc. This includes developing new and revising current general chapters and developing references standards to support vaccines. Standards for new analytical technologies. Developing standards to broadly support different vaccine modalities. Documentary and physical standards to support raw and starting material quality
assessment.
2025-20
- 30 KEY ISSUESDeveloping method based general chapters and physical standards to address vaccine quality assessment for mRNA, viral vectored, protein subunit, inactivated, an
- d attenuated.Standards for raw and starting material qualit
y assessment.
REQU
IRED EXPERTISEThe expert volunteer should have experience in one or more of the following areas for one or more vaccine modality (mRNA, viral vectored, glycoconjugate, protein subunit, inactivated
- , attenuated):Analytical cha
- racterization,Manufacturing processes and qu
- ality control,Methods development, a
nd validation.PREFE
RRED EXPERTISEThe expert volunteer should have experience in one or more of the fo
- llowing areas:Formulatio
- n development,Methods to monitor contr
- ol impurities.Quality control of raw and start
- ing materials.Understanding of USP rev
- ision process.Understanding of the US and international regulations for protein
therapeutics.
FOCUS AREA - Cell and
Gene Therapies
2025-2030 FOCUSStandards and guidelines to support cell and gene therapies. This includes developing new and revising current general chapters and developing references standards/materials to support cell and gene therapies. Standards for current and emerging analytical technologies in this field. Developing standards to broadly support different therapeutic classes, including in vivo end ex
vivo therapies.
2025
- -2030 KEY ISSUESStandards and guidelines to support adeno-associated virus (AAV) and Lentiviral (LV) based ge
- ne therapeutics.Standards to support quality assessment of raw materials and starting materials for cell and
- gene therapies.Developing documentary and physical standards to support new analytical technologies to address common quality attributes for cell and
gene therapies.
R
EQUIRED EXPERTISEThe expert volunteer should have experience in one or more of the following areas for one or more class of cell o
- r gene therapies:analytical
- characterization,bioassay development, manufacturing processes and
- quality control,methods
- developmen
t, andvalidation.Experience with characterization or production of one or more of the followi
- ng pro
- duct typ
- es:CAR-T,AAV, andLV
based therapies.
Voluntee
- r Time RequirementMust be able to contribute average of 5 hours per week w
- ith some variationMeetings: 1 to 2 face-to-face official meetin
- gs per fiscal yearTeleconferences held as needed for official meetings an
d working sessions
Travel 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 attendan
ce per 5-year cycle
