Sr Scientist II, Biologics

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

The Senior Scientist II role is a non-supervisory position that is responsible for development and evaluation of reference materials and methods to support development and maintenance of USP standards and tools. Technical focus for this position is on standards and controls for quantitation of biomarkers, especially using a variety of immunoassays. In addition to laboratory work, the incumbent in this role is expected to lead interactions with external research partners and stakeholders, present data externally, write a variety of scientific manuscripts, and be a strong advocate for standardization of biomarker assays.

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.
Standards and tools that support quality and consistency of analytical methods for both existing and new therapeutic modalities are critical for improving the efficiency of biologics development. This position will support development and maintenance of reference materials and tools by performing testing, method development, and method qualification/validation to support standards for protein biomarkers. The successful candidate will interact with internal groups as well as external collaborative laboratories as appropriate.

The Scientist II has the following responsibilities:

• Develops, qualifies, and implements functional and some physiochemical methods to support the biologics portfolio with emphasis on immunoassays. Develops workplans, analyzes data and prepares reports, manuscripts and slides for internal and external publication and presentation. Participates in additional reference standard testing, such as stability studies and replacement lot testing.
o Extensive experience in immunoassays and evaluation of standards/controls that are part of immunoassay kits or can supplement such kits.
o In depth understanding of analytical chemistry and biological principles.
o Able to operate independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
• Collaborates with a cross-functional team, including colleagues in the US and India to design and implement studies, solve issues, analyze data, review results, define next steps, and support transfer of analytical methods. Leads interactions with external stakeholders and research partners.
o Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
o Strong communication (written and oral) preparation and presentation skills and ability to tailor and deliver content and presentations to internal and external stakeholders.
o Act as a strong advocate for standardization of biomarker assays.
• Supports laboratory operations and global biologics program by following laboratory processes, sharing knowledge with colleagues, supporting adoption of new approaches and process improvements. Maintains and troubleshoots instrumentation.
o Capability to build technical expertise in others by serving as a mentor.
o Ability to lead both internal and external projects.
o Ability to learn new technologies and strong computer, scientific, and organizational skills.

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:

• M.S. in Biochemistry or related field and 15 years of relevant laboratory experience.
• Ph.D. in Biochemistry or related field with 10 years of relevant laboratory experience.
• Strong interpersonal, written and verbal communication skills.
• Ability to work independently and to handle multiple priorities in a fast-paced environment; strong scientific, computer and organizational skills.

Additional Desired Preferences

• Technical hands-on expertise in development and application of immunoassays, both singleplex (ELISA) and multiplex (preferably MSD and Luminex platforms). Expertise in understanding, sourcing, handling and characterization of protein standards and controls used in these assays.
• Experience in designing and executing method validation or qualification following industry guidelines (such as CLSI, CLIA, ICH).
• Experience in developing and managing external collaborations and partnerships and demonstrated ability to deliver high quality presentations to a variety of stakeholders.
• Additional experience in using common analytical techniques (such as advanced quantitation methods, Flow cytometry, CE, HPLC, MS) for characterization of protein standards/controls is preferred.
• Working experience in the pharmaceutical and/or biotechnology industry strongly preferred.

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 $130,250.00 – $164,750.00 annually.
Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s 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