Scientist IV, Reference Standards Evaluation
Scientist IV, Reference Standards Evaluation
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Job Description
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 hands-on non-supervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS)/Analytical Reference Materials (ARMs) including but not limited to pharmaceutical analytical impurities extractables & leachables polymers and certified reference materials (CRMs). This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for all candidate lots technical assistance for collaborating labs analytical data review and preparation of summary reports preparation of packaging and Quality Control testing instructions
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 SIII/SIV position has the following responsibilities:
- Responsible for timely preparation of testing protocols for new/replacement reference materials technical assistance for collaborating labs
- To review the analytical data received from the Collaborators and to prepare summary reports preparation of packaging and QC testing instructions and assigning periodic re-test intervals. Independently maintains successful scheduling operations necessary documents complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
- Coordinate with labs and reviews/interprets data from international collaborative studies.
- To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
- To provide guidance on the interpretation of test data Proposes and designs studies to obtain necessary data to resolve complaints.
- To support Documentary Standard team by peer review of draft monograph
- To demonstrate technical understanding to internal and external audiences regarding USPs Reference Standards program.
- Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
- Presents information to USP staff and external audiences.
- Facilitates additional cross-functional activities with other departmental staff and other USP staff.
- Performs other related duties as assigned.
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:
Scientist IV
- MSc in chemistry or related field with 8-10 yrs of experience (or) Ph.D. in chemistry or related field with 3-5 yrs of experience
Scientist III
- MSc in chemistry or related field with 6-8 yrs of experience (or) Ph.D. in chemistry or related field with 1-3 yrs of experience with the following skills
- Hands on experience in interpretation of results characterization of the compound by spectral techniques (NMR MASS and IR).
- Knowledge on chromatographic techniques (HPLC GC)
- Ability to handle multiple priorities in a fast-paced environment.
- Excellent written and verbal communications skills.
Additional desired preferences:
- Ability to read and interpret spectroscopic analyses data (NMR IR MS etc.)
- Hands on experience on chromatographic techniques such as (HPLC GC).
- Prior experience with materials characterization using a variety of analytical techniques.
- Prior experience with lab investigations.
- Stability studies exposure.
Supervisory Responsibilities: NA
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.
Employment Type
Full-Time
