The U.S. Pharmacopeial Convention (USP) Scientist III, CDL (Excipients) in Hyderabad, India
Scientist III, CDL (Excipients)
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.
This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.
Roles and Responsibilities
Search relevant literature for the USP/NF monograph modernization projects.
Provide effective technical and scientific expertise in analytical method development and validation of excipients/ pharmaceuticals.
Plan individually the project requirements and their completion within the time lines by coordinating with the supervisor and team.
Responsible for preparation and review of SOPs, protocols, reports, etc.
Preparation of development & validation reports for respective USP/NF monograph modernization projects.
Ensure that the calibrations of the equipment are performed as per the schedule.
Responsible for preparing, executing and completing IQ/OQ/PQ of instruments.
Indent the required glass ware, chemicals and columns for the CDL projects.
Maintain GLP & safety procedures while working in Lab.
Presentation on the project pipeline and outcomes with the management will be a part of job.
Master’s Degree in Chemistry with 6-8 years of experience. Possess a fine understanding of USP/NF monographs/general chapters/general notices.
Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
Good analytical skills in handling method developments and validations for Excipients and pharmaceuticals. Awareness of ISO/IEC 17025 is desirable.
Master’s Degree in Chemistry or Pharmaceutical Sciences with 6-8 years of experience or PhD with at least 1-3 years of experience in relevant field. Exceptional breadth of excipient/pharma industry experience.
Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm.
Technical and analytical skills required including the ability to interpret technical information.
Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, GPC/SEC-MALS, IC, ICP-OES/MS, FTIR, UV-Visible, NMR, AAS and KF.
Should have fair understanding of GLP regulations and exposed to external regulatory audits. Should possess strong technical knowledge in the areas of complex molecules/compounds such as polymers, fats, oils, waxes and plants
Hyderabad, Andhra Pradesh, India
Job Category Scientific