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

Scientist III, Bioassay

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Job Description

This is a hands-on, non-supervisory position in USP-India’s Biologics Bioassay Laboratory. In this position, the Scientist will perform in vitro assays for various biologics product class such as Recombinant Proteins and mAbs, Peptides, Blood Products etc. Scientist will be responsible for hands-on execution of projects on collaborative testing of reference standards, characterization of biological products, method development and validation and contributing towards various project types of USP-NF (Documentary Standards, Physical Reference Standard & Performance Standards). In addition, the Scientist will also actively engage and contribute in Verification testing program, USP Education program and other international and national RS development programs. The Scientist will execute 100% of their work at the bench level and contribute in cross functional area(s) such as Molecular biology, Microbiology and Physico-chemical characterization of Biologics as per requirement.

Roles and Responsibilities:

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

  • Independently executes all testing / analysis, and records experimental data ensuring clear and accurate transcription of results and calculations

  • Independently plans and executes Compendial projects, Verification and R&D projects, and drafts and reviews project reports for submission.

  • Participates in laboratory management activities

  • Formulates technical presentations and participates in scientific discussion meetings.

  • Coordinates with cross functional team members across global sites and within USP India.

  • Undertakes training courses and provides training to new joinees and existing scientists as appropriate

  • Designs and develops variety of technical platforms in area of in vitro Bioassays

  • Executes Microbial assays and physico-chemical analytical tests.

  • Demonstrates compliance to USP’s QMS systems and best practices.

  • Demonstrates strong skills and expertise in laboratory methods and troubleshooting

  • Reviews, and evaluates scientific literature in areas of biotherapeutics, Food and Dietary supplements.

  • Independently implements and evaluates laboratory procedures and systems

  • Keeps open mind and takes inputs from peers, stakeholders and customers to deliver projects of high quality on time

  • Demonstrates strong desire towards continuous learnings

  • Performs other duties as assigned

Required Skills

  • M.Sc. in Biotechnology, Biochemistry, Microbiology or any other related stream with 6-8 years of experience in Bioassay & related area(s).

  • Experience in Microbial assays and bioanalytical tests methods is desirable.

  • Working experience with specialized instruments such as Coagulation Analyzer and Flow Cytometer is desirable.

  • Sound knowledge and practical experience with Biotherapeutic products is required.

  • Strong expertise in cell banking & characterization, in vitro cell based/cell free potency assays, and data analysis software is must.

  • Knowledge of clean room requirements, calibration and operation of analytical instruments, establishment of systems and processes is required.

  • Strong understanding of QMS and excellent communications skills are essential.

Required Experience

  • Experience with working in cGLP environment and qualification/validation of bioassay methods is highly desirable.

  • The candidate must take personal responsibility to ensure work is delivered on time and is of the highest quality.

  • Should demonstrate ability to troubleshoot and solve technical problems.

  • Working knowledge of lab management systems and practices including Inventory Management system is strongly preferred.

  • Should have strong communication and presentation skill, in addition should demonstrate good collaboration skills.

Job Location

Hyderabad, Andhra Pradesh, India

Position Type


Job Category Scientific