Senior Scientist I

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the

worlds 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 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 professional individual contributor position that will be part of the Healthcare, Quality & Safety (HQS)

Center of Excellence under the Personalized Medicines group. This role will be responsible for leading the

development of future standards and solutions for Pharmacogenomics and Software as a Medical Device that

address the needs of healthcare professionals. This includes partnership and collaboration with USP Expert

Committees, external experts and cross-functional teams on exploring key topics such as pharmacogenomics,

digital medicine, SaMD and other emerging areas. The incumbent will lead critical evaluation of relevant

literature, scientific data and evidence and development of priority standards and solutions. This position will

collaborate with documentary scientists in the Healthcare Quality and Safety group, incorporating global

perspectives and helping to shape the engagement strategy pharmacogenomics and SaMD stakeholders and USP

solutions.

In addition, this position coordinates and facilitates the workplans related to the above with all relevant USPs

Expert Committees and healthcare practitioner input into USP standards-setting activities. This individual will

drive outreach to key stakeholders at key conferences and related events and coordinate development of key

stakeholder forums, workshops, roundtables and education to foster engagement and promote adoption of these

standards.

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:

Works with the Director, Personalized Medicine to lead the development of research summaries, draft

standards, concept papers, stimuli articles, and other position papers on personalized medicines. Support the

establishment of USP Personalized Medicine Expert Committee and its subcommittees as important

convening bodies for the development of compendial standards that drive the adoption of pharmacogenomics,

digital therapeutics (e.g., SaMD) and personalized medicine in general.

Utilizing the USP case-based approach, lead the planning and organizing of the personalized medicines

standard setting activities of the four HQS expert committees (Personalized Medicine, Healthcare Information

& Technology, Healthcare Safety, Quality, and Nomenclature and Compounding). Develop a comprehensive

workplan for these activities in the cycle and beyond, spelling out the composition and types of

standard setting bodies (e.g. expert committees, subcommittees, Joint subcommittees, advisory panels, expert

panels, etc).

Advocate USPs position as a leading standard setting organization for personalized medicine by seeking out

and holding interactions with a diverse set of stakeholders. Identify opportunities for and lead on the

development and delivery of presentations and other deliverables to external stakeholders on current and

future USP personalized medicine standards. Represent USP in various personalized medicine stakeholder

interactions. Participates in the development and implementation of enhanced initiatives for stakeholder

engagements on draft and final standards such as open stakeholder forums, workshops, roundtable discussions

and other events.

Guide the systematic development of briefing materials for and lead in the scheduling of all expert volunteer

activities leading to the development of personalized medicines standards and related products. Lead and

manage the activities of expert volunteers for the personalized medicines expert committee, research fellows,

student interns and other temporary staff that USP may bring on to support these efforts.

Support the interface between HQS and cross-functional/global teams on USP personalized medicine

standards to ensure work integration and alignment with inter-departmental workplans. Identify opportunities

for and collaborate with cross-functional teams at USP in the development of implementation tools for

personalized medicines, such as education course development, verification programs and digital tools.

Secure services as needed from other departmental, divisional, and organizational groups.

Utilize internal and external resources to systematically collect and regularly compile relevant scientific

information and data pertaining to USP current and future personalized medicines standard setting activities,

and curate this information for dissemination via various USP communication channels such as website

updates, newsletters, outreach emails, etc.

Keeps abreast of and regularly update USP colleagues and relevant collaborators about current trends and

developments in personalized medicines especially application of new healthcare technologies,

pharmacogenomics, digital therapeutics and other emergent areas. Provide recommendations for potential

application and impact of these developments to personalized medicines activities at USP generally.

Liaise between USP and governmental inter-agency activities at international, federal and state level (e.g.

EMA, FDA, CDC, NABP) on personalized medicines areas of common interest to USP.

Drives global outreach to key USP regional teams and Global Health and Manufacturing Services department

to identify and engage with global stakeholder organizations. This includes presenting at international and national meetings and participating in relevant discussions. Provides assistance and guidance for standards

that can impact global health stakeholders.

Possesses understanding of compounding monographs, general chapters and various USP policy issues both

internally and externally including response to inquiries and stakeholder issues.

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:

Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 5 years (or MS and 7 years)

of relevant experience in compounding, personalized medicines, pharmacogenomics, digital therapeutics,

digital medicine, SaMD, or related field; alternatively pharmaceutical, biotechnology or life science industry

experience may be applicable. An equivalent combination of experience and education may be substituted

(e.g., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).

Possesses knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and/or codes as they

relate to personalized medicine. Possesses knowledge of the FDAs Drug Quality and Security Act of 2013,

FDA policy guidance on regulation of medical devices, pharmacogenetic tests and genetic tests for heritable

markers, submission of pharmacogenomic data for drug labels . click apply for full job details