U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist II-CHM in Hyderabad, India

Description

Summary of the Position

This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP/NF/FCC method development and method validation projects and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business, and the incumbent is expected to support monograph modernization initiatives.

Roles and Responsibilities

  • Literature search for the USP/NF/FCC projects.

  • To ensure the project's requirements by coordinating with the Group Leader.

  • To involve in project execution, method development, and validation of USP/ NF/FCC projects.

  • To ensure the knowledge on different drug product handling and sample preparations.

  • Provided effective technical and scientific expertise regarding drug substance and drug product analytical development

  • Engage in project planning, execution, method development, and validation of projects according to set standards as USP general chapters, guidelines, SOPs, and protocols.

  • Ensure the project updates are provided to the supervisor regularly.

  • To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.

  • Responsible for preparation and review of SOPs, protocols, reports, etc.

  • Responsible for the review of the records and documents.

  • To ensure that the calibrations of the equipment are performed as per the schedule.

  • Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.

  • To indent the required glassware, chemicals, and columns for the USP/NF/FCC projects.

  • To maintain GLP & safety procedures while working in Lab.

Basic Qualifications

  • Master’s Degree in Chemistry with 3-5 years of experience.

  • Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.

  • Exposure to GMP/GLP/QMS environment and documentation procedures and champions data integrity.

  • Should be capable of performing analytical method developments and method validations using modern techniques and protocols.

  • Good analytical skills in handling method development and Validations for Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures.

  • Awareness of ISO/IEC 17025 is desirable.

Preferred Qualifications

  • Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of experience.

  • Excellent technical writing and oral communication skills required.

  • Must be able to communicate effectively with diplomacy and enthusiasm.

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

  • Must have hands-on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.

  • Should have a fair understanding of GLP regulations and exposed to external regulatory audits

Supervisory Responsibilities

NA

Qualifications

Experience

Required

  • Drug development

  • Chemical Analysis

  • HPLC

  • Method Validation

  • Method development

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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