The U.S. Pharmacopeial Convention (USP) Scientist III - Bioassay 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 laboratory and will 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 also work on molecular biology methods like DNA/RNA extraction, PCR,RT-PCR, agarose gel electrophoresis etc. for mAbs and vaccine products. 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 laboratory.
Roles and Responsibilities
Performs immune assay (ELISA) and cell-based potency assays as required.
Performs PCR, RT-PCR, gel electrophoresis etc. for mAbs and vaccine products
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, cell-based 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
Supports in departmental trainings as applicable.
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
Sc. in Biochemistry, or related Biological Science field with 7-8 years of Industrial experience in vaccine quality testing, mAb functional and cell based assays.
An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating potency assays for monoclonal antibodies. Candidate must be experienced in Immunoassays, Fc functional assays like ADCC, CDC etc.
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.
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.
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