Scientist Iv, Reference Standards Laboratory

**Description**

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.

**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?**- Executes all testing and analysis of data with excellence and essentially no errors.- Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing and project review whenever needed.- Responsible for preparation of project evaluation reports.- Coordination with supervisor to ensure completion of the projects allotted to the team.- Initial review of the project reports and documents and assisting the group leader when required.- Completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.- 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.- Taking up any additional responsibilities assigned by Supervisor from time to time.- Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.- Mentoring and training juniors in team for day-to-day analysis.

**Who USP is Looking For?**
- Ph.D. in Chemistry or Master’s degree in chemistry / Pharmacy.

**Experience**:
- Proven track record of consistently delivering projects on time and with high quality for API’s.- Expert in chromatographic analysis, particularly in HPLC and GC.- Proficient in other related analytical instrumentation such as Titration, IR, KF, UV, Thermal analysis, Elemental analysis, etc.- 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 and Electronic Laboratory Notebook, ERP, QR coding system is an added advantage.- Hands-on experience in handling instruments like ICP-OES/MS, IC, LC-MS, and GC-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**
- None

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