The U.S. Pharmacopeial Convention (USP) Scientist II, RSL in Hyderabad, India
Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts 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 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, to the partnerships we build, to the conversations we foster, we affirm the crucial value of Diversity, Equity, Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare. Part of this commitment includes an emphasis on professional development of all staff and leadership training for managers. These include advancing core competencies such as Inclusive Management Style, Coaching/Mentorship and Adaptive Leadership to name a few.
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, 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
Brief Job Overview
This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in collaborative testing, efficient and effective laboratory operations.
How will you create impact here at USP?
Executing the analytical tests allotted by Project Leader or Group Leader.
Responsible for completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
Coordination with group leader to ensure completion of the projects allotted to the team.
Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
Responsible for the initial review of the project reports, documents and assisting the group leader when required.
Taking up any additional responsibilities assigned by group leader from time to time.
Responsible for preparation and review of SOPs, protocols, reports etc.
Responsible for performing the calibration of the equipment as per the schedule.
Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
Responsible to maintain and follow QMS and should handle incidents and deviations.
Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.
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:
Must have a Master’s degree in M.Sc. (analytical or organic), M. Pharma (pharmaceutical sciences or analysis) with 3 to 6 years relevant laboratory experience.
Proven track record of consistently in completing the tests on time, with high quality for formulation and API’s.
Proficient in chromatographic analysis, particularly in HPLC, GC.
Proficient in handling other related analytical instruments such as Auto titrator, KF, FTIR, UV spectrometer, Thermal equipment’s, Elemental analyzer, SOR, TLC etc.
Proficient in wet chemical analysis.
Must possess effective communication skills, both written and verbal.
Should have knowledge of Empower software.
Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
Should have a strong understanding of GLP regulations and exposure to external regulatory audits.
Additional Desired Preferences
Having knowledge of Lab Management System (LMS) and Electronic Laboratory Notebook, ERP, QR coding system is an added advantage.
Hands-on experience in handling instruments like MS is an added advantage.
Understanding monograph procedures and participating in compendial methods for reference materials (USP, FCC, NF, etc.).
Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or Analytical R&D, or a contract pharmaceutical analytical laboratory testing organization is a plus.
Awareness of ISO/IEC 17025 is desirable.
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 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