The U.S. Pharmacopeial Convention (USP) Scientist II (Bioanalytical) – Biologics in Hyderabad, India
Scientist II (Bioanalytical) – Biologics
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action
Summary of the Position
This is a hands-on, non-supervisory position in which the incumbent applies their knowledge and practical experience in execution of bioanalytical projects on collaborative testing of reference standards, documentary standards and characterization of biological products. Additionally, the incumbent will also actively engage and contribute in verification, international and national reference standard development programs as assigned.
Roles and Responsibilities
Aligns with USP’s mission, goals and objectives; complies with USP’s guidelines and other requirements.
Plans and executes Compendial, Verification and R&D projects for product classes such as proteins, monoclonal antibodies, peptides, antibiotics and any other biological products as assigned.
Prepare project reports as per USP’s quality systems and procedures.
Demonstrates strong skills and expertise in Bioanalytical methods in the areas of Chromatography, Colorimetric assays, Electrophoresis & Mass spectrometry.
Routinely applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory.
Complies with USP’s Quality Management System and assists group leaders in implementing process improvements.
Performs other duties as assigned.
M.Sc./M. Tech./M. Pharm. in relevant stream of biological sciences with 4-6 years of relevant experience in working with biologics product class.
Experience should include strong technical knowledge and practical experience in Bioanalytical area.
Work experience in cGLP/cGMP environment is desirable.
M.Sc. (Biochemistry / Biotechnology)/ M. Tech (Biotechnology / Bioprocess engineering)/ M. Pharm with expertise on techniques like HPLC, UPLC, Colorimetry, Spectrophotometry & Electrophoresis (IEF, SDS-PAGE, Western Blot)
Expertise in Mass Spectrometry (Characterization/Quantification) & Capillary Electrophoresis would be preferred.
Understanding of QMS along with good communication skills is a must.
Ability to plan, design, execute, trouble shoot, and resolve technical issues within the scope.
Job Category Laboratories