Scientific Affairs Manager ( Biologics

Description

Who is USP?

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

As part of USP’s mission to advance scientific rigor and strengthen public health globally, this role contributes to expanding access to high-quality medicines through public standards and related programs.

The Scientific Affairs Manager plays a critical role in communicating and amplifying USP’s science across the region, strengthening scientific visibility and external engagement with customers, regulatory authorities, and key stakeholders. The position supports the understanding, adoption, and appropriate applications of USP compendial standards including analytical methods, reference standards, and impurity controls across pharmaceutical and selected biopharmaceutical products.

This role translates complex scientific and technical content into clear, impactful engagement strategies and insights, while capturing regional scientific and regulatory intelligence to inform organizational priorities and planning.

This is a remote Non
- Supervisory position residing in one of the following states:
New Hampshire, Maryland, DC, Virginia, Pennsylvania, North Carolina, or Florida, requiring up to 60% domestic travel.

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 Scientific Affairs Manager, Nor Am, Has The Following Responsibilities

Scientific Engagement & Technical Support:

• Provide scientific guidance on the application and adoption of USP–NF monographs, general chapters, and compendial analytical methods, including validation, verification, and system suitability.
• Advice on the selection, qualification, and lifecycle management of USP Reference Standards in accordance with compendial expectations.
• Provide support and technical input to stakeholders on impurity profiling, control strategies, analytical method development, transfer, troubleshooting, and compendial compliance in alignment with USP standards and ICH guidelines.

Stake…