Work as Bioassay Scientist at U.S. Pharmacopeial Convention

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Post : Scientist III, Bioassay

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.

• 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
• Seeks out innovative ways to apply knowledge or skills to improve protocols and results
• 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.

Candidate Profile
• 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.

• 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 outcomes.
• Individual must possess the ability to handle multiple priorities in fast-paced environment.
• Knowledge/participation of reference standards development related to bio pharmaceutical products/industry.
• Experience with reference materials development is a plus.

Additional Information
Experience : 6-8 years
Qualification : MSc
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Bioassay
End Date : 31st July 2025