Scientist Ii, Reference Standard Laboratory

**Description**

**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?**

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.- Executes analytical tests as assigned by the Project Leader or Group Leader.- Ensures project completion within timelines and troubleshoots scientific issues as needed.- Coordinates with the group leader to ensure team projects are completed.- Manages sample archival, sample tracking, and chemical inventory in the laboratory.- Ensures availability of chemicals and columns for projects and forwards purchase requisitions.- Performs equipment calibration as per the schedule.- Prepares, executes, and completes IQ/OQ/PQ of new instruments.- Prepares and reviews SOPs, protocols, and reports.- Conducts initial reviews of project reports and documents, assisting the group leader when required.- Takes on additional responsibilities assigned by the group leader as needed.- Maintains lab safety and GLP practices, and actively participates in internal and external audits and certifications.- Follows QMS protocols and handles incidents and deviations.- Supports Verification, GPH, PQM, stability, and other departmental teams with testing and project reviews as needed.

**Who is USP Looking For?**- Experience: 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 and 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.- Expert in Empower software with knowledge on Audit trails and Custom fields.- 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.

**Supervisory Responsibilities**

No

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

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

Who is USP?

The U.S. Pharmacopeial Convention (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 1,300 hard-working professionals across twenty 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, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be c