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Post : Scientist III / Senior Scientist I CDL
• Search relevant literature for the USP/NF monograph modernization projects.
• Responsible for the modernization / development project (initiation, execution, reporting, & completion).
• Should have worked on chromatography (HPLC, GC), mass spectrometry (LC- MS/MS, GC- MS/MS) techniques.
• Should have experience of method development and validations (DS/DP/Excipients).
• Responsible for design, review, and execution of method development experiments and perform method validation in accordance with laid down procedure.
• Responsible for preparation of method validation protocols and reports.
• Plan individually the project requirements and their completion within the time lines by coordinating with the supervisor.
• Responsible for procurement of chemicals, reagents, glassware, columns, project related samples, and general requirement on regular basis.
• Responsible for preparing regular project updates and communicating with internal customers through verbal and email communication.
• Responsible for preparation and review of SOPs, protocols, reports and ELNs.
• Responsible for instrument maintenance and ensuring good lab practices.
• Ensure that the calibrations of the equipment are performed as per the schedule.
• Responsible for review of IQ/OQ/PQ documents of instruments.
• Coordinate with supervisor for internal audits, ISO17025 and ISO9001.
• Maintain GLP & safety procedures while working in Lab.
• Master’s degree in Chemistry or relevant field.
• Minimum of 8-10 years (Senior Scientist I) or 5-7 years (Scientist III) of experience in the field of analytical method development and validations.
• Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 8-10 years (Senior Scientist I) or 5-7 years (Scientist III) years of experience or PhD with at least 3-4 years of experience in relevant field.
• A candidate with an experience of analyzing genotoxic impurities (such nitrosamines) using LC-MS-MS and GC-MS-MS will be preferred
• Knowledge and exposure of analytical QbD approach.
• Excellent written and verbal communications skills.
• Technical and analytical skills required including the ability to interpret technical information.
• Must have hands on experience on handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible etc.
• Must have experience of working in GMP environment and have exposure of regulatory guidelines.
• Ability to handle multiple priorities in a fast-paced environment.
Location : Hyderabad, India
Industry Type : Pharma
Functional Area : CDL
End Date : 30th Januaray, 2022