Description
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 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 USP’s
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, 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 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 2025 – 2030 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 USP’s 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 FDA’s 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, Compliance Policy Guide (CPG) for both
human and animal drug use, and other.
- Understanding of current challenges and opportunities for the increased utilization of pharmacogenomics
information in healthcare decision making at all health system levels. Knowledge of or involvement in the
activities of key stakeholder collaboration groups like STRIPE. Knowledge of existing stakeholder guidelines
for nomenclature, testing, health equity, data integration into electronic health records and clinical decision
support systems, healthcare practitioner education and models of care in pharmacogenomics.
- Understanding of current challenges and opportunities for the increased incorporation of digital therapeutics
in drug formularies (both Software as a Medical Device – SAMD and Software in a Medical Device –
SIMD). Knowledge of existing stakeholder recommendations for current implementation challenges with
digital therapeutics a plus. Knowledge of or involvement in the activities of key stakeholder collaboration
groups like Digital Therapeutics Alliance (e.g. terminologies and definitions, categorization and classification,
labeling, expectations of quality, evidence evaluation, privacy and security, version control).
- Understanding of USP standards-setting processes and compendial terminology. Knowledge of global
pharmaceutical and healthcare industries and related trade associations.
- Strong analytical skills and ability to work on basic processes as well as strategic initiatives required.
Expertise in evaluating research of evidence-based information. Demonstrates creativity, flexibility, and the
ability to develop and review effective Expert Committee and Expert Panel work plans consistent with
organizational mission and objectives.
- Strong presentation and overall communication skills, both written and oral.
Additional Desired Preferences
- Able to effectively prioritize and efficiently manage multiple activities.
- Able to operate independently where appropriate yet understand when to escalate issues and how to establish
effective working relationships in a team setting.
- Experience in hospital-based or community pharmacy compounding a plus.
- Understanding and knowledge of organizational development within the context of non-profits.
- Operates collaboratively at all levels of the organization in a highly technical environment.
- Well-developed organizational, interpersonal communications, negotiation, writing, attention to detail, and
strong listening skills.
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.
Compensation
Base Salary Range: USD $110,500.00 – $144,000.00 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
