USP Biologics - Member

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 - Therapeutic Peptides, Oligonucleotides and Complex Carbohydrates​

2025-2030 FOCUS

Standards 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/products.

2025-2030 KEY ISSUES

• Development of the first monograph to support
• therapeutics.
• Standards to support species analysis for heparin products.
• Revisions of monographs for recombinant peptides to address new synthetic products.

REQUIRED EXPERTISE

Understanding 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 modalities:

• Setting specifications,
• Manufacturing processes and quality control, and
• Methods development and validation.

PREFERRED EXPERTISE

The expert volunteer should have experience in one or more of the following areas for one or more of these modalities:

• Setting specifications,
• Manufacturing processes and quality control,
• Formulation development, and
• Methods development and validation.
• Characterizing synthetic and/or recombinant therapeutic peptides and methods to monitor impurities.
• Microbial and HPLC-based assay methods, methods to monitor control impurities, and
• Modernizing release methods.
• Understanding of USP revision process.
• Understanding of the US and international regulations for one or more of these 3 modalities.

FOCUS AREA - Therapeutic Proteins

2025-2030 FOCUS

Standards 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 antibodies.

2025-2030 KEY ISSUES

• Developing documentary and physical standards to support binding and bioassays for protein therapeutics.
• Developing documentary and physical standards to support new analytical technologies for protein characterization.

REQUIRED EXPERTISE

The expert volunteer should have experience in one or more of the following areas:

• Analytical characterization of protein therapeutics, bioassay development,
• Manufacturing processes and quality control,
• Methods development, and validation.
• Experience with characterization or production of one or more of the following product types of Insulins, enzymes, and monoclonal antibodies.

PREFERRED EXPERTISE

The expert volunteer should have experience in one or more of the following areas:

• Formulation development,
• Methods to monitor control impurities.
• Understanding of USP revision process.
• Understanding of the US and international regulations for protein therapeutics.

FOCUS AREA - Vaccines

2025-2030 FOCUS

Standards 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.

2025-2030 KEY ISSUES

• Developing method based general chapters and physical standards to address vaccine quality assessment for mRNA, viral vectored, protein subunit, inactivated, and attenuated.
• Standards for raw and starting material quality assessment.

REQUIRED EXPERTISE

The 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 characterization,
• Manufacturing processes and quality control,
• Methods development, and validation.

PREFERRED EXPERTISE

The expert volunteer should have experience in one or more of the following areas:

• Formulation development,
• Methods to monitor control impurities.
• Quality control of raw and starting materials.
• Understanding of USP revision process.
• Understanding of the US and international regulations for protein therapeutics.

FOCUS AREA - Cell and Gene Therapies

2025-2030 FOCUS

Standards 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 ISSUES

• Standards and guidelines to support adeno-associated virus (AAV) and Lentiviral (LV) based gene 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.

REQUIRED EXPERTISE

The expert volunteer should have experience in one or more of the following areas for one or more class of cell or gene therapies:

• analytical characterization,
• bioassay development, manufacturing processes and quality control,
• methods development, and
• validation.
• Experience with characterization or production of one or more of the following product types:
• CAR-T,
• AAV, and
• LV based therapies.

PREFERRED EXPERTISE

• The expert volunteer should have experience in one or more of the following areas formulation development, methods to monitor control impurities.
• Quality assessment of raw and starting materials.
• Understanding of USP revision process.
• Understanding of the US and international regulations for cell and gene therapies.

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.