U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist III / Senior Scientist I CDL in Hyderabad, India

Description

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.

Basic Qualifications

  • 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.

Preferred Qualifications

  • 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.

Supervisory Responsibilities

  • None

Note:

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

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