Senior Scientist I, Reference Standard Evaluation, USP
Job Overview
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Date PostedJune 1, 2025
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Location
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Expiration dateJuly 1, 2025
Job Description
The Senior Scientist I is a hands-on, non-supervisory position in the Reference Standards Evaluation
(RSE) Department within Global Lab & Technical Operations (GLTO). The incumbent is responsible
for designing and writing the reference standards qualification test protocols and Reference Standard
Candidate Evaluation Packages (RSCEPs) in support of reference standards for use in USP monographs,
preparing Reference Standard Certificate, Packaging Configuration Forms, and other reference standard
related documents, conducting any investigations based on customer complaints and internal findings,
attending Expert Committee meetings, Reference Standards Ballot meetings as needed. The incumbent is
also expected to support departmental quality initiatives.
This position reports to the Manager and interacts on a regular basis with other Reference Standard
Scientists and Managers in RSE, and stakeholders in other USP functions as Reference Standard
Technical Operations, Reference Material Support, Reference Materials Acquisition, QA, Reference
Standards Laboratory, Documentary Standard, and Reference Standards Production.
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, USP’s 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, Reference Standards Evaluation, has the following responsibilities:
- Independently designs collaborative studies and prepares test protocols/documents for reference
standard candidates in accordance with established SOP’s, Operation Manuals, and policies. The
incumbent will be responsible for ensuring the protocols contain sufficient and appropriate
identity and purity tests to properly characterize reference standard candidates.
- Evaluates collaborative study data for potential candidate materials with regard to their
suitability for use in USP-NF compendia.
- Authors the Reference Standards Candidate Evaluation Packages (RSCEPs) in accordance with
established SOP’s, Operation Manuals, and training documents.
- Works professionally and collaboratively with fellow Reference Standard Scientists, Reference
Standards Technical Operations staff, Reference Standards Laboratory staff, Documentary
Standard Scientists, Reference Standards Production staff, Reference Materials Acquisition staff,
And Other Relevant Departments As Required.
- Independently identifies and implements solutions to technical problems related to the
development of reference standards and the analysis of the data.
- Assists in quality related investigations resulting from customer complaints to include root cause
analysis, corrective action identification, action planning, and implementation monitoring.
- Independently prepares technical presentations as needed for reference standard investigations
and expert committee meetings.
- Performs other duties as assigned.
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 or related field with at least five (5) years of relevant experience; or MS in
Chemistry or related field with at least seven (7) years of relevant experience; or BS in
Chemistry or related field with at least ten (10) years of relevant experience.
Additional Desired Preferences
- Prior knowledge of working with and/or qualifying reference standards for drug substances, drug
products, dietary supplements (botanical/non-botanical), and excipients.
- Working knowledge and/or experience of analytical technology such as NMR, qNMR, Mass Spec.,
IR, DVS, chromatographic techniques such as HPLC, GC, IC etc.
- Strong skills in troubleshooting and solving technical problems.
- Good understanding of the impact of reference standards in compliance setting.
- Excellent written and verbal communications skills.
- Proven ability to write scientific/technical documents (protocols, reports, investigations, etc).
- Proven ability to work collaboratively with other functions and desire to work well with diverse
employees in a professional manner.
- Proven ability to establish effective working relationships.
- Proven ability to operate independently where appropriate yet understand when to escalate issues.
- Proven ability to prioritize and manage multiple, concurrent projects in a fast-paced and highvolume environment with changing deadlines and priorities.
- Proven ability to work flexible hours when needed to meet the project timelines.
- Experience with, and knowledge of the USP-NF and use of reference standards.
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