Senior Scientist I, Reference Standard Evaluation

BioSpace; Rockville (MD); On-site; USD 110,000 - 144,000; Full time

Job summary

A leading organization in public health standards is seeking a Senior Scientist I to enhance global access to high-quality medicines. This role involves designing test protocols, collaborating with experts, and ensuring compliance with rigorous quality standards. The ideal candidate will have a Ph.D. in Chemistry or equivalent experience, strong analytical skills, and a commitment to scientific integrity. Join a diverse team dedicated to advancing public health solutions.

Benefits

Comprehensive healthcare options

Retirement savings

Company-paid time off

Qualifications

• 5+ years of experience in relevant field.
• Strong skills in troubleshooting and solving technical problems.

Responsibilities

• Designs and writes reference standards qualification test protocols.
• Conducts investigations based on customer complaints.
• Authors Reference Standards Candidate Evaluation Packages.

Skills

Collaboration

Analytical Skills

Problem Solving

Communication

Education

Ph. D. in Chemistry

MS in Chemistry

BS in Chemistry

Tools

NMR

Mass Spec.

HPLC

GC

Job description

Senior Scientist I, Reference Standard Evaluation

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Senior Scientist I, Reference Standard Evaluation

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Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates

Description

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 1,300 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

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, 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, Reference Standards Evaluation, has the following responsibilities:

Independently designs collaborative studies and prepares test protocols/documents for reference

standard candidates in accordance with established SOPs, 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 SOPs, 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.

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 $110,500.00 $144,000.00 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Internet News

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