Senior Scientist I, General Chapters

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a non-supervisory scientific role in the Compendial Science/General Chapters Group focused on analytical chemistry and standards for assessing and controlling organic and inorganic impurities. The Senior Scientist I supports the development and revision of USPNF General Chapters and related documentary standards partnering closely with Expert Committees and associated Expert Panels. The role requires critical evaluation of technical data and literature international guidelines hands-on method execution experience when needed and clear scientific writing aligned to USP editorial style and format. The incumbent will help translate complex datasets into defendable proposals and publications and respond to stakeholder inquiries throughout the standard-setting process.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Senior Scientist I will have the following responsibilities:

• 40% Support the development revision and maintenance of USPNF General Chapters focused on analytical chemistry. including evaluating scientific data conducting literature reviews drafting proposals and ensuring alignment with USPs documentary standards processes. The incumbent will participate in the development of standards pertaining to impurities testing (including elemental and organic impurities) as well as other relevant USP General Chapters topics as required.
• 30% Engage with Expert Committees Expert Panels and external stakeholders by preparing scientific materials facilitating discussions responding to inquiries and representing USPs science with clarity and accuracy.
• 15% Contribute to laboratory-related feasibility studies and reportable results assessments to support data-driven recommendations for standards.
• 10% Support cross-functional initiativesincluding digital tools operational excellence activities and environmental sustainability effortsto strengthen USPs quality systems workflows and scientific outputs.
• 5% Advance USPs culture of inclusive excellence by modeling equitable practices supporting collaborative team environments and engaging in continuous learning aligned with USPs mission and values.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

• Ph.D. in Chemistry Analytical Chemistry Chemical Engineering or a closely related scientific discipline with a minimum of five (5) years of relevant experience in analytical chemistry inorganic impurities analysis or related fields.

OR

• Masters degree (MS) in Chemistry Analytical Chemistry Chemical Engineering or a related field with a minimum of seven (7) years of relevant experience.

OR

• Bachelors degree (BS) in Chemistry Analytical Chemistry Chemical Engineering or a related field with a minimum of ten (10) years of relevant experience.

Additional Desired Preferences

• Demonstrated familiarity with USPs documentary standardssetting processes including General Chapters monographs and reference standards development.
• Extensive expertise in identifying and characterizing both organic and inorganic impurities along with a thorough understanding of regulatory guidelines for mutagenic impurities.
• In depth knowledge of ICH Q3 guidance and ICH M7 is a plus.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being is protected.

Compensation

Base Salary Range: USD $112700 $146900 annually.
Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Senior IC