The U.S. Pharmacopeial Convention (USP) Scientist II - Compendial Development Laboratory in Hyderabad, India
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF/FCC monographs 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.
How will YOU create impact here at USP?
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 standardsas 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.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
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 or APIs or Drug products. Awareness of ISO/IEC 17025 is desirable.
Goodhands on experience in working with chemical methods and handling instruments like HPLC (Empower software), UHPLC, GC, FTIR, UV-Visible, and KF. Should have fair understanding of GLP regulations and exposed to external regulatory audits.
Additional Desired Preferences
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 LC-MS, GC, GC-MS, GPC/SEC-MALS, IC, ICP-OES/MS. 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.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can haveyou can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Chemistry & Scientific Standards
Job Type Full-Time