The U.S. Pharmacopeial Convention (USP) Scientist II - Compendial Development Laboratory in Hyderabad, India
Search relevant literature for the USP/NF monograph modernization projects.
Responsible for the complete lifecycle of the monograph modernization / development project (initiation, execution, reporting, & completion).
Responsible for method development and validations (DS/DP/Excipients), using chromatography (HPLC, GC) techniques.
Should have worked on chromatography (HPLC, GC) 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.
Engage in project planning, execution, method development and validation according to set standards as USP general chapters, guidelines, SOPs and protocols.
Plan individually the project requirements and their completion within the timelines by coordinating with the supervisor and team.
Responsible for regular maintenance of assigned instruments.
Ensure that the calibrations of the equipment are performed as per the schedule.
Responsible for review of IQ/OQ/PQ documents of instruments.
Indent the required glass ware, chemicals, and columns for the CDL projects.
Maintain GLP & safety procedures while working in Lab.
- Master’s Degree in Chemistry with 3-5 years of experience. Possess a fine understanding of USP/NF monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols. Good analytical skills in handling method developments and validations for Excipients and pharmaceuticals. Awareness of ISO/IEC 17025 is desirable.
- Master’s Degree in Chemistry or Pharmaceutical Sciences with 3-5 years of experience in relevant field. Exceptional breadth of excipient/pharma industry 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. Good to have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, GPC/SEC-MALS, IC, ICP-OES/MS, FTIR, UV-Visible, NMR, AAS and KF. Should have fair understanding of GLP regulations and exposed to external regulatory audits. Should possess strong technical knowledge in the areas of complex molecules/compounds such as polymers, fats, oils, waxes and plants
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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
a reasonable accommodation is approved.
Job Category Chemistry & Scientific Standards
Job Type Full-Time