Description
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 confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Brief Job Overview
The Senior Scientist I is a hands-on, non-supervisory position in the Reference Standards Evaluation (RSE) Department within Global Lab & Technical Operations (GLTO). The incumbent is responsible for designing and writing the reference standards qualification test protocols and Reference Standard Candidate Evaluation Packages (RSCEPs) in support of reference standards for use in USP monographs, preparing Reference Standard Certificate, Packaging Configuration Forms, and other reference standard related documents, conducting any investigations based on customer complaints and internal findings, attending Expert Committee meetings, Reference Standards Ballot meetings as needed. The incumbent is also expected to support departmental quality initiatives.
This position reports to the Manager and interacts on a regular basis with other Reference Standard Scientists and Managers in RSE, and stakeholders in other USP functions as Reference Standard Technical Operations, Reference Material Support, Reference Materials Acquisition, QA, Reference Standards Laboratory, Documentary Standard, and Reference Standards Production.
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.
The Senior Scientist I, Reference Standards Evaluation, has the following responsibilities:
- Independently designs collaborative studies and prepares test protocols/documents for reference standard candidates in accordance with established SOP’s, Operation Manuals, and policies. The incumbent will be responsible for ensuring the protocols contain sufficient and appropriate identity and purity tests to properly characterize reference standard candidates.
- Evaluates collaborative study data for potential candidate materials with regard to their suitability for use in USP-NF compendia.
- Authors the Reference Standards Candidate Evaluation Packages (RSCEPs) in accordance with established SOP’s, Operation Manuals, and training documents.
- Works professionally and collaboratively with fellow Reference Standard Scientists, Reference Standards Technical Operations staff, Reference Standards Laboratory staff, Scientific Liaisons, Reference Standards Production staff, Reference Materials Acquisition staff, and other relevant departments as required.
- Independently identifies and implements solutions to technical problems related to the development of reference standards and the analysis of the data.
- Assists in quality related investigations resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring.
- Independently prepares technical presentations as needed for reference standard investigations and expert committee meetings.
- Performs other 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
- Ph.D. in Chemistry or related field with at least five (5) years of relevant experience; or MS in Chemistry or related field with at least seven (7) years of relevant experience; or BS in Chemistry or related field with at least ten (10) years of relevant experience.
Additional Desired Preferences
- Prior knowledge of working with and/or qualifying reference standards for drug substances, drug products, dietary supplements (botanical/non-botanical), and excipients.
- Working knowledge and/or experience of analytical technology such as NMR, qNMR, Mass Spec., IR, DVS, chromatographic techniques such as HPLC, GC, IC etc.
- Strong skills in troubleshooting and solving technical problems.
- Good understanding of the impact of reference standards in compliance setting.
- Excellent written and verbal communications skills.
- Proven ability to write scientific/technical documents (protocols, reports, investigations, etc).
- Proven ability to work collaboratively with other functions and desire to work well with diverse employees in a professional manner.
- Proven ability to establish effective working relationships.
- Proven ability to operate independently where appropriate yet understand when to escalate issues.
- Proven ability to prioritize and manage multiple, concurrent projects in a fast-paced and high-volume environment with changing deadlines and priorities.
- Proven ability to work flexible hours when needed to meet the project timelines.
- Experience with, and knowledge of the USP-NF and use of reference standards.
Supervisory Responsibilities
None.
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.
Compensation
Base Salary Range: USD $110,500 – $144,000 annually.
Target Annual Bonus: 13% Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.
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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time
