Scientist Iv, Reference Standards Evaluation

**Description**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s 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 minds—regardless of background—to 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 position in Reference Standard Evaluation department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS), Pharmaceutical Analytical Impurities (PAI) and Certified Reference Materials (CRMs) or any other physical materials USP intend to develop. The position is expected to contribute majorly in PAI activities. It is more of an operational and tactical role. This incumbent is responsible for, including but not limited to, timely preparation of procurement specification, collaborative testing protocols for RS, PAIs, CRMs, providing technical assistance for collaborating labs, analytical data review, preparation of scientific/technical reports, Certificates, Product Information Sheet (PIS), defining and preparation of packaging configuration, Quality Control testing instructions, resolving technical issues.

**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 Scientist S-IV, RSE has the following responsibilities:
- Responsible for managing the development of PAIs by working in collaboration with internal and external stakeholders/partners as necessary- Item creation, reviewing the data package from partners, preparation of packaging and labelling forms (PLF)- Preparing the documentation including, but not limited to, the test protocol, PAI report, product information sheet.- Communicate with internal stakeholders and external partner as and when required- Addressing customer queries and complaints promptly after doing necessary investigation- To have ability to do “Problem solving” at any step of development process

Contribution to regular Reference Standard development process as and when required, that involves- Responsible for timely preparation of procurement specifications and collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs-
- To have discussion with Scientific Liaison (SL) and Expert Committee (EC) members during new monograph or monograph modernization processes. Participating in peer review of draft monograph before submission to Pubs.- To Draft product planning documents (PPD), coordinates with labs, and reviews/interprets data from international collaborative studies.- Submits collaborative study summary reports to review and subsequent approval for each RS lot. Addresses the concerns of balloters to achieve successful approval of RSCEPs.- To have ability to do “Problem solving” at any step of RS development process.- To produce quality documents (RSCEP, Addenda, TP) with minimum comments from RSTO and no “Major” observation from QA.- To Coo