The U.S. Pharmacopeial Convention (USP) Scientist III / Senior Scientist I CDL in Hyderabad, India
Roles and Responsibilities
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.
As a condition of employment with United States Pharmacopeia-India Private Limited’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
Job Category Chemistry & Scientific Standards
Job Type Full-Time