U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Scientist III Biologics in Hyderabad, India


Summary of the Position:

This is a hands-on, non-supervisory position in USP-India’s Biologics Bioassay laboratory. In this position, the Scientist will spend 80-100% of the time in lab and will perform ligand binding assays using SPR (Surface Plasmon Resonance) technology.

In addition, scientist will also perform in vitro cell based assays for various biologics product class such as recombinant proteins and mAbs, peptides, blood products, etc. as required. Scientist will be responsible for hands-on execution of projects on 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 lab.

Roles and Responsibilities

  • Performs ligand binding assays using SPR technology, ELISAs etc.

  • Performs cell-based potency assays as required.

  • Develops and evaluates methods used for the measurement of biological attributes, develops validation protocols, and execute the validation plans. Prepares final report and presents data as applicable

  • Evaluates and analyzes scientific reports and identifies next steps and key challenges. Plan and conduct research projects independently

  • Works with cross-functional teams within the organization to solve/support both technical and process-related issues.

  • Performs peer-review of data along with collaborative test and research reports

  • Keeps abreast of current trends and developments in related scientific fields, particularly in mAbs functional assays.

  • Demonstrates strong technical skill, interest, and expertise in binding and functional assays

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

  • Actively engages in overall project and ensures own work is aligned with overarching goals

  • Shares technical expertise with junior fellow lab staff and serve as a mentor for them

  • Assists team lead in planning, implementing, and evaluating laboratory procedures/systems

  • Attends scientific seminars and conferences

  • Follows GLP and QMS practices. Recommend improvement to systems and all other supporting activities as assigned by the team lead.

  • Aligns with USP’s mission, and complies with USP’s guidelines and other requirements

Basic Qualifications

  • Sc. in Biochemistry, or related Biological Science field with 7-8 years of Industrial experience in mAb binding assays and/ or Ph.D. in Biochemistry or related biological science field with 2-3 years of relevant laboratory/Industrial experience

  • An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise in handling SPR based instruments and developing ligand binding assays (LBA). Candidate must be experienced in immuno assay and binding assays in other formats.

Preferred Qualifications

  • Experience in cell culture techniques and cell-based bioassays. Knowledge in development and validation of potency assays is a plus. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination, including but not limited to, parallel line analysis methods.

  • Working experience in the pharmaceutical and/or biotechnology industry strongly preferred

  • Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.

  • Strong writing skills and experience drafting technical reports related to project proposal, material characterization, method development etc.

  • Ability to learn new technologies and strong computer, scientific, and organizational skills

  • Ability to summarize and present data at meetings to a wide range of audiences

  • Must possess excellent 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 of reference standards development related to biopharmaceutical products/industry.

  • Experience with reference materials development is a plus.

Supervisory Responsibilities



USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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.

Note: As a condition of employment with United States Pharmacopeia- India Private Limited’s

(USP), duty to provide and maintain a workplace that is free of known hazards, all employees and

contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a

a reasonable accommodation is approved.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

Job Category Chemistry & Scientific Standards

Job Type Full-Time