The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Scientist III, AR&D
This is a non-supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Scientist III works on projects including Analytical Method Development and Compendia Analytical method validation. The Scientist III performs a variety of routine analytical tests, including evaluation of reference standards, development or validation of official methods, evaluation of packaging materials, stability and dissolution studies, and general research in analytical chemistry.
Roles and Responsibilities:
• Execute projects per the approved test protocols.
• Ensure the projects requirements by coordinating with the Purchasing department.
• Involve in project acceptance & approvals.
• Coordinating with Senior Scientist to complete ARD projects within timelines.
• Responsible for preparation and review of SOPs, protocols, reports, etc.
• Preparation of development & validation reports for ARD projects.
• Responsible for review the records and documents.
• Ensure that the calibrations of the equipments are performed as per the schedule.
• Prepare, execute and complete IQ/OQ/PQ of new instruments.
• To indent the required glass ware, chemicals and columns for the AR&D projects.
• Maintain GLP & implement safety procedures while working in Lab.
• Perform RSL Projects whenever free from ACRL activities.
• Perform other duties as assigned.
Ph.D. in Chemistry with a minimum 2-3 years of experience / Master’s degree in Chemistry with a minimum of 5 years of experience in analytical testing and development. Exposure to GMP/GLP environment and documentation procedures required. Ability to perform analytical method developments and method validations required.
Knowledge, Skills & Abilities:
Experience in handling mass spectrometric instruments like GC-MS, LC-MS and ICP-MS with a strong theoretical background in terms of spectral interpretation is required. Knowledge of working with HPLC, GC, FTIR, UV-Visible, etc. and wet chemical analysis is desirable. Knowledge of working with XRD would be an added advantage. The incumbent must be able to communicate effectively with both internal and external customers and have a working knowledge of computer applications, such as MS Word and Excel.
Experience: 2-3 years
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
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