Director, Compendial Science Digital Integration
The United States Pharmacopeial Convention / USP
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Job summary
USP, based in Rockville, MD, seeks a Director of Compendial Science Digital Integration to modernize USP’s standards-development ecosystem. You will bridge compendial science with digital innovation, delivering machine-readable and executable standards while leading cross-functional teams and ensuring scientific rigor across analyses and workflows.
The role requires extensive expertise in analytical methodologies, laboratory operations, and digital integration, with responsibility for
Qualifications
- Bachelor’s degree in analytical chemistry, chemistry, pharmaceutical sciences, life sciences, chemical engineering, bioinformatics, computer science, engineering, or related field required.
- Minimum of three (3) years of experience managing, supervising, mentoring, and/or leading a team.
- Minimum of eight (8) years of progressively responsible experience in pharmaceutical, biopharmaceutical, analytical laboratory, standards-setting, regulatory, or related scientific environments.
Responsibilities
- Provide scientific oversight for Digital Standards strategy and Digital Reference Standards.
- Define scientific requirements, validation expectations, and fitness-for-purpose criteria for digital representations of compendial content.
- Identify opportunities to modernize compendial science through analytical technologies, data science, and responsible AI.
Skills
Education
Tools
Job description
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.
The Director, Compendial Science Digital Integration is a scientific leadership role responsible for modernizing and digitally integrating USP’s compendial standards-development ecosystem. The role bridges compendial science, analytical laboratory practice, and digital innovation to advance trusted, scalable, machine-readable, and computational approaches to standards development and use.
This leader will help shape the digital standards frameworks, establish scalable scientifically sound processes, and advance responsible AI-enabled capabilities that improve efficiency, interoperability, accessibility, and future readiness. The position requires strong technical knowledge of analytical methodologies and demonstrated leadership in analytical laboratory environments, including practical application of the USP compendia, laboratory automation, and digitalization of laboratory workflows.
The position will connect scientific, technical, digital, regulatory, quality, and enterprise stakeholders to translate USP’s digital strategy into practical solutions for compendial science. The role will partner closely with the VP of Compendial Science Transformation.
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.
In this role, you will help modernize how USP develops, structures, governs, and delivers public quality standards, enabling more efficient scientific workflows and broader access to trusted compendial content. You will help establish the scientific foundations required to translate compendial knowledge into human-readable, machine-readable, and, where appropriate, machine-executable forms.
You will also lead cross-functional adoption of digital tools, laboratory automation, responsible AI practices, data standards, and interoperable approaches that improve consistency, transparency, traceability, and impact across standards-development and laboratory workflows.
- Provide scientific oversight into the realization of USP’s Digital Standards strategy, including Digital Reference Standards and Digital Documentary Standards.
- Define scientific requirements, validation expectations, and fitness-for-purpose criteria for digital representations of compendial content while preserving scientific rigor, traceability, and compendial authority.
- Identify opportunities to modernize compendial science through emerging analytical technologies, data science, computational methods, and responsible use of artificial intelligence.
- Lead science facing initiatives that integrate digital tools, automation, and data‑driven approaches into analytical laboratory and standards-development workflows.
- Guide the integration of compendial standards with laboratory informatics and execution environments, including LIMS, LES, ELN, CDS, and enterprise quality systems.
- Advance machine-readable compendial methods, with structured scientific content.
- Partner with technology, product, and laboratory teams to translate scientific and user requirements into practical, scalable digital solutions.
- Oversee the scientific aspects of content architecture, data models, metadata, and digital publishing across the standards-development lifecycle.
- Explore and implement appropriate uses of responsible AI for scientific information discovery, content structuring, quality checks, workflow support, and stakeholder‑insight synthesis.
- Support data governance, provenance, version control, validation, human oversight, and lifecycle-management requirements for digital and AI-enabled capabilities.
- Lead the Scientific Stewardship Subteam within the Digital Standards Transformation and coordinate scientific input across digital, documentary, regulatory, policy, and quality functions.
- Serve as a key connector across USP by applying deep knowledge of analytical methodologies, compendial science, laboratory operations, and digital integration.
- Build alignment among scientific, technical, regulatory, quality, product, and enterprise stakeholders, and influence complex initiatives in a matrixed environment.
- Provide strategic recommendations to the VP of Compendial Science Transformation and senior leaders regarding scientific modernization priorities, risks, capabilities, and investments.
- Represent USP in scientific, regulatory, technology, and industry forums related to digital standards, laboratory automation, digital quality, and emerging analytical technologies.
- Develop productive relationships with pharmaceutical manufacturers, regulators, technology providers, standards organizations, and academic collaborators.
- Monitor relevant developments in artificial intelligence, machine learning, knowledge graphs, digital twins, computational standards, laboratory automation, and data interoperability, and translate them into practical opportunities for USP and its stakeholders.
- Bachelor’s degree in analytical chemistry, chemistry, pharmaceutical sciences, life sciences, chemical engineering, bioinformatics, computer science, engineering, or related field required.
- Minimum of three (3) years of experience managing, supervising, mentoring, and/or leading a team.
- Minimum of eight (8) years of progressively responsible experience in pharmaceutical, biopharmaceutical, analytical laboratory, standards-setting, regulatory, or related scientific environments.
- Demonstrated leadership experience in analytical laboratories or laboratory-centered scientific organizations, including responsibility for scientific programs, laboratory operations, analytical methods, technology implementation, or multidisciplinary teams.
- Deep knowledge of analytical methodologies used in pharmaceutical testing and practical experience applying USP compendial standards, including monographs, General Chapters, Reference Standards, method validation, and pharmaceutical quality expectations.
- Demonstrated experience leading laboratory automation, digitalization, informatics, or technology-enabled workflow improvement initiatives.
- Working knowledge of laboratory systems and digital integration concepts, including LIMS, LES, ELN, CDS, data standards, APIs, interoperability, structured content, and digital traceability.
- Experience leading complex cross‑functional initiatives and influencing scientific, regulatory, quality, digital, and business stakeholders without direct authority.
- Excellent communication, presentation, and interpersonal skills, including the ability to synthesize complex scientific and technical information and translate it into clear strategies, decisions, presentations, and reports.
- Advanced degree in analytical chemistry, pharmaceutical sciences, chemistry, chemical engineering, life sciences, bioinformatics, computer science, engineering, or a related discipline preferred.
- Experience with digital standards, structured scientific content, computational methods, ontologies, knowledge graphs, or machine-executable scientific workflows.
- Knowledge of responsible AI and machine learning applications in analytical science, laboratory operations, scientific content, or pharmaceutical quality.
- Experience with enterprise technology transformation, product development, data governance, digital quality systems, or platform implementation.
- Experience working in a matrixed and global organization and communicating effectively across cultures.
- Demonstrated change leadership, including the ability to build adoption of new technologies, operating models, and scientific practices.
Yes, 1-3 direct reports.
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.
Base Salary Range: USD $ 171,833- $243,289 annually.
Target Annual Bonus: % 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.
As part of the recruitment process, USP's Global Talent Acquisition team may contact candidates through a variety of communication channels, including Microsoft Teams, telephone, email, and WhatsApp (voice calls and text messages). These communications may be used to schedule interviews, provide updates on application status, discuss career opportunities, and answer questions about employment with USP.
To help ensure timely communication, candidates are encouraged to keep their contact information current and to engage only with individuals who clearly identify themselves as authorized USP representatives. USP will never request payment, banking details, or other financial information as part of the hiring process.
Chemistry & Scientific Standards
Full‑Time
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