Scientist IV, Reference Standards Evaluation

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

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 minds—regardless of background—to 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 Evaluation department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS), Pharmaceutical Analytical Impurities (PAI) and Certified Reference Materials (CRMs) or any other physical materials USP intend to develop. The position is expected to contribute majorly in PAI activities. It is more of an operational and tactical role. This incumbent is responsible for, including but not limited to, timely preparation of procurement specification,  collaborative testing protocols for RS, PAIs, CRMs , providing technical assistance for collaborating labs, analytical data review, preparation of  scientific/technical reports, Certificates, Product Information Sheet (PIS), defining and preparation of packaging configuration, Quality Control testing instructions, resolving technical issues.

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, USP’s 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 Scientist S-IV, RSE has the following responsibilities:

• Responsible for managing the development of PAIs by working in collaboration with internal and external stakeholders/partners as necessary
• Item creation, reviewing the data package from partners, preparation of packaging and labelling forms (PLF)
• Preparing the documentation including, but not limited to, the test protocol, PAI report, product information sheet.
• Communicate with internal stakeholders and external partner as and when required
• Addressing customer queries and complaints promptly after doing necessary investigation
• To have ability to do “Problem solving” at any step of development process

Contribution to regular Reference Standard development process as and when required, that involves

• Responsible for timely preparation of procurement specifications and collaborative testing protocols for new/replacement RS lots, technical assistance for collaborating labs
• To review the analytical data received from the Collaborators and to prepare summary reports and Reference Standard Candidate Evaluation Package (RSCEP), 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.
• To have discussion with Scientific Liaison (SL) and Expert Committee (EC) members during new monograph or monograph modernization processes. Participating in peer review of draft monograph before submission to Pubs.
• To Draft product planning documents (PPD), coordinates with labs, and reviews/interprets data from international collaborative studies.
• Submits collaborative study summary reports to review and subsequent approval for each RS lot. Addresses the concerns of balloters to achieve successful approval of RSCEPs.
• To have ability to do “Problem solving” at any step of RS development process.
• To produce quality documents (RSCEP, Addenda, TP) with minimum comments from RSTO and no “Major” observation from QA.
• To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
• To provide correct guidance on the interpretation of test data, Proposes and designs studies to obtain necessary data to resolve complaints.
• To demonstrate technical understanding to internal and external audiences regarding USP's Reference Standards program.
• Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
• Performs and participate in 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:

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:

• PhD in Chemistry/Pharmacy from a recognized University. Minimum of 4-7  years of Pharmaceutical industry experience
• MSc/MPharm from a recognized University. Minimum 8-10 years of Pharmaceutical industry experience
• Hands on experience on chromatographic techniques (HPLC, GC)
• Must have strong experience in analytical method development and analytical method validation
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.

Additional Desired Preferences

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

• Prior knowledge of working with and/or qualifying reference materials
• Adequate laboratory experience to handle sophisticated analytical equipment’s
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.
• Ability to operate independently where appropriate, yet understand when to escalate issues and how to establish effective working relationships.
• Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects in a fast-paced and high volume environment with changing deadlines and priorities
• Able to work flexible hours when needed to meet the project timelines
• Strong skills in troubleshooting, and solving technical problems.
• Experience with, and knowledge of the USP-NF is preferred.
• Basic knowledge / familiarity with statistical analysis

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 specific written agreement with USP.