The U.S. Pharmacopeial Convention (USP) Scientist II, Biologics in Hyderabad, India
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, vaccines 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 (HPLC/UPLC), Electrophoresis/Capillary Electrophoresis, Colorimetric assays and Enzyme assays
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
Follows and ensures aspects related to safety, ethics, and legal compliance
Performs duties for the allocated lab/equipment’s/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned
Demonstrates a strong desire to continue learning and grow personal capability
Supports cross functional activities in Biologics lab under supervision as per requirement
Assists in quality audits as necessary
Performs other duties as assigned
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
Sc (Biochemistry / Biotechnology)/ M.Tech (Biotechnology / Bioprocess Engineering)/ M. Pharm with expertise on techniques like, HPLC/UPLC with various detectors, Ion chromatography, Colorimetry, Spectrophotometry & Electrophoresis (IEF, SDS-PAGE, Western Blot)
Capillary Electrophoresis & Mass Spectrometry are not mandatory but would be an added advantage
· Understanding of QMS along with good communication skills is a must
- Good written and verbal communications skills
USP offers an impressive benefits package, including:
· Comprehensive individual and family health insurance plans
· Annual Master Health check-up plans
· Generous paid holidays, vacation leave
· Transportation services for office commute.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit 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.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods 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.
Job Category Chemistry & Scientific Standards
Job Type Full-Time