U.S. Pharmacopeial Convention Jobs

Job Information

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

Description

This is a hands-on supervisory position responsible for the modernization of monographs included in USP-NF and the development of new monographs / iterative standards. The incumbent in this role will be responsible for supervising a team involved in the development and validation of analytical methods for small molecules (drug substance and drug products). The responsibilities in this position include managing the entire life-cycle (lab request, procurement, execution, and reporting) of monograph modernization or a new monograph development project. This position will directly impact USP’s mission of strengthening the global supply of quality medicine and becoming a definitive source of quality standards. The incumbent in this position need to co-ordinate with internal customers such as Scientific Liaisons (SLs) and other support function such as procurement and quality assurance (QA).

Roles and Responsibilities

  • Responsible for maintaining GLP & safety procedures in Lab.

  • Coordinate and provide technical assistance to procurement team for procuring the required materials for the assigned projects according to the sample acquisition request submitted by internal customers (Scientific Liaisons).

  • Tracking and reviewing the lab requests submitted by internal customers (SLs). Arranging kick-off meetings to discuss on scope and timeline of the projects.

  • Supervise and guide the team members in execution and report preparation (method development and validation) of the projects according the operation manual.

  • Reviewing the final reports and ensure timely completion of the projects according to the lab requests.

  • Circulating the final reports to the internal customers (SLs) and quality assurance and addressing their comments.

  • Supervise and guide the team members to ensure implementation of the quality management system (SOP, deviations, change controls, etc.,).

  • Provide overall status of the assigned projects to supervisor on regular basis.

  • Provide support during the internal and external quality audits (ISO9001 and ISO17025).

  • Communicate with global teams on project updates and other activities.

  • Ensure proper preventive maintenance of the instruments and scheduled periodic calibrations (review of calibration, IQ/OQ/PQ documents).

  • Provide support to EHS and ensure implementation of safety procedures.

  • Support other stakeholders (such USP education, External affairs, etc.)

Preferred Qualifications

  • Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 12 years of experience or PhD with at least 5-6 years of experience in relevant field.

  • Knowledge and exposure of analytical QbD approach.

  • Excellent written and verbal communications and presentation skills.

  • Technical and analytical skills required including the ability to interpret technical information.

  • Must have hands-on experience in 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.

  • Able to work flexible hours when needed. In addition to normal business hours of 8:00 a.m. 4:30 p.m. Monday through Friday, serves on a team to provide 24 hours a day, 7 days a week response to emergency alarm calls and can be available on short notice to support requests during unusual hours, especially early or late in the day during the business week.

Supervisory Responsibilities

  • Direct reports at Scientist I, Scientist II, Scientist III, and Senior Scientist I level

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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