Scientist Iii, Bioassay

**Description**

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 hands-on, non-supervisory position in USP-India's Biologics laboratory. In this position, the scientist will spend 80-100% of the time in laboratory and will perform bioassays and binding for various biologics product class such as recombinant proteins and mAbs, perform vaccine and cell and gene therapy (CGT) functional characterization assays, and viral assays. Scientist will be responsible for hands-on execution of projects which can be collaborative testing of reference standards, characterization of biological products, method development and validation for development of standards (Documentary Standards, Physical Reference Standard & Performance Standards). Responsible for supporting activities related to India Biologics laboratory.

**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.- Proficient in _in vitro_ cell based relative potency.- Proficient in handling cell lines and primary cells. Experienced in functional activity and immunogenicity assays.- Proficient in flow cytometry.- Experienced in method qualification and validation, protocol, report writing and data presentation.- Plans and executes research projects independently. Evaluates and analyzes scientific reports and identifies next steps and key challenges.- Works with cross-functional teams within the organization to solve/support both technical and

process-related issues.- Performs peer-review of collaborative testing reports and research reports.- Keeps abreast of current trends and developments in related scientific field.- Shares technical expertise with junior colleagues and serves as a mentor for them-
- Assists team lead in planning, implementing, and evaluating laboratory procedures/systems- Supports in departmental trainings as applicable.- Attends scientific seminars and conferences- Supports lab management activities- Follows GLP and QMS practices. Recommend improvement to systems and all other supporting

activities as assigned by the team lead. Participates in internal and external audits.- Aligns with USP's mission, and complies with USP's guidelines and other requirements- Performs other duties as assigned.

**Who is USP Looking For?**

**Example**:
- MSc. in Biochemistry, or related Biological Science field with 6-8 years of Industrial experience in bio pharmaceutical product development and quality testing, relative potency assays, mAb functional assays, expertise in flow cytometry, and primary cell culture. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination.- An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating assays, and QMS knowledge and experience.

**Additional Desired Preferences**- Working experience in the biotechnology/biopharmaceutical industry strongly preferred.- Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.- Ability to learn new technologies and strong computer, scientific, and organizational skills.- Good written and verbal communication skills, time management skills as well as interpersonal skills.- Results driven with demonstrated successful outc