Job Description

Description 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 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. Responsible for Inventory management and other supporting activities related to Biologics. Scientist will execute 100% of their work at the bench level and contribute in cross functional area(s) as per the requirement. Roles and Responsibilities: Executes all testing / analysis, and records experimental data ensuring clear and accurate transcription of results and calculations under supervision

• Plans and executes Compendial projects, R&D projects and PoC project under supervision for product classes such as proteins, monoclonal antibodies, peptides, Vaccines, and any other biological products as assigned

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

• Demonstrates strong skills and expertise in laboratory methods

• Participates in laboratory management activities and coordinates with cross functional team members at USP India

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

• Demonstrates strong desire towards continuous learnings and performs other duties as assigned

Basic Qualifications MSc. in Biochemistry, or related Biological Science field with 4-6 years of Industrial experience in mAb functional and cell-based assays. Practical experience working with Biotherapeutics products primarily in Bioassay is required. Expertise in cell culture techniques and 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 good communications skills are preferred. Preferred Qualifications 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 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 Responsibilitie s None Job Category Chemistry & Scientific Standards Job Type Full-Time