Senior Scientist I, Reference Standards Laboratory

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

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

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Senior Scientist I has the following responsibilities:

• Execution of allotted tests and completing the project as per timelines and troubleshoot the scientific aspects of the projects as on need basis.
• Coordination with Lab staff and supervisor to maintain the Lab as per GLP and safety practices.
• Verify and approve the project related Test protocols and Test kits received from RSE/CSU departments and any other supporting work from other departments on a needy basis.
• Supporting Verification and other departmental teams in terms of project review and approval whenever needed.
• Overall planning and coordination of all RSL projects as needed.
• Compilation of project reports and response to QA observations.
• Initial review of projects reports and final project review of other teams projects on a required and priority basis.
• Completing the projects as per the project timelines and priorities.
• Preparation and review of SOPs.
• Providing hands on training to the new joiners and existing reporting staff whenever required.
• Ensuring the calibration of the equipment as per the schedules.
• Planning chemicals column. Glassware etc. and their procurement by coordination with lab operation and purchase department in advance keeping in mind the project deadlines.
• To maintain good relationship with other departments.
• Preparation executing and completing IQ/OQ/PQ of new instruments.
• Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively verification of protocols and related documents and take an active role in the internal as well as external audits and address the audit issues on a timely manner.
• Taking up any other additional responsibilities assigned by supervisor on a proactive basis.
• To involve in and support the laboratory investigations to identify and correct the issues.
• Maintaining proper communication with RSE / QA in resolving the technical issues.
• Has the responsibility to maintain internal databases consistently.

Who is USP 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.

• 7 to 10 years with relevant laboratory experience for Ph.D. candidates.
• 11 to 13 years with relevant laboratory experience for Masters degree candidates.
• Proven track record of consistently delivering projects on time and with high quality for APIs.
• Expert in chromatographic analysis particularly in HPLC GC and IC.
• Proficient in other related analytical instrumentation such as Mass Spectrometry Titration IR KF UV Thermal analysis Elemental analysis etc.
• Must possess effective communication skills both written and verbal.
• Should have thorough knowledge of Empower software Custom fields audit trails review etc.
• 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 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 this is an individual contributor role.

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 specificwritten agreement with USP.

Required Experience:

Senior IC