US Pharmacopeia

Support Engineer

• Respond to questions received in the USP customer email boxes related to USP compounding standards.
• Draft clear, accurate responses using established guidance, HQS resources, and subject matter expert input aligned with program messaging.
• Identify common or emerging topics suitable for stakeholder capability building activities.
• From the queries, facilitate updates to public facing FAQs for USP , , and compounded preparation monographs, ensuring accuracy, clarity, and alignment with the official standards.
• Shape AI modules that address technical standards-based queries helping to refine answers and improve system capabilities.
• Perform review, consolidation, and preparation of materials in support of the Compounding Documentary Standards Scientist.

Senior Scientist I, Technical Support Compounding

Implementation Specialist

• Develop internal policy frameworks for the creation, governance, structure, and lifecycle management of USP Digital Standards.
• Lead the development of USP’s external policy positions for FDA, EMA, ICH, WHO, and other regulatory bodies related to Digital Standards, structured data submissions, and digital quality expectations.
• Draft regulatory comment letters, issue briefs, white papers, and policy analyses that articulate USP’s perspectives on digital standardization, data governance, and digital regulatory pathways.
• Represent USP in external policy‑focused working groups, standards bodies, and technical committees (e.g., ICH, ISO, PQ/CMC, Pistoia Alliance).
• Translate policy decisions into actionable implementation guidance, schemas, metadata requirements, and integration specifications for use by industry, technology vendors, and internal product teams.
• Collaborate with USP scientific, digital, and standards‑setting teams to ensure Digital Standards are developed in alignment with regulatory expectations and structured data principles.
• Provide subject‑matter expertise during Digital Standards pilot efforts, ensuring that pilots validate USP’s policy frameworks and deliver value to stakeholders.
• Monitor global regulatory and policy trends and provide insights and recommendations to internal leadership.
• Develop internal guidance documents, governance models, SOPs, and best practices that ensure consistency and compliance in the creation of Digital Standards.
• Support the development of thought‑leadership content on Digital Standards and digital regulatory transformation.

Senior Digital Standards Policy and Implementation Manager

Solutions Engineer

• Lead strategic engagement with pharmaceutical companies, regulators, and other relevant stakeholders to promote the adoption of USP’s digital standards in regulatory filings.
• Develop and manage pilot programs with early adopters to validate the use of digital standards in real-world regulatory scenarios.
• Collaborate cross-functionally with USP’s scientific, regulatory, and digital teams to align industry needs with solutions development.
• Represent USP externally at industry forums, conferences, and regulatory roundtables to advocate for digital standards and share pilot outcomes.
• Build and maintain strategic partnerships with key stakeholders across industry, regulatory agencies, contract organizations, and technology providers.
• Monitor and report on adoption metrics, feedback from pilot participants, and market trends to inform strategy and product evolution.
• Personally lead early pilot execution to demonstrate the value of Digital Standards.

Senior Digital Standards and Industry Solutions Manager

Director

• Define and execute the roadmap for AMT products and services in close collaboration with AMT team and other groups at USP
• Drive revenue growth for AMT product lines and services
• Lead technical proposal development for US government opportunities of both bespoke and standardized service offerings, especially in the biopharmaceutical space
• Define, develop, launch, and manage the physical materials portfolio to support companies using advanced pharmaceutical and biologics manufacturing with close coordination with USP materials program and relevant program unit teams
• Gather, analyze, and continuously update customer insights to inform product development and ensure offerings address real-world challenges in manufacturing and testing
• Identify and prioritize market opportunities across pharma, biotech, and government sectors
• Translate AMT’s strategic priorities into market-ready offerings
• Oversee stage-gate processes for product and service development
• Manage lifecycle from concept through launch and post-market optimization while collaborating with AMT technical, GHMS external communications, and GHMS federal practice teams
• Develop go-to-market strategies, pricing models, and commercialization plans for new offerings and recommend positioning strategies for existing offerings to the market opportunities
• Work closely with GHMS business development and federal practice teams to identify and cultivate strategic alliances and partnerships with industry, technology innovators, academia, and government agencies to accelerate adoption of advanced technologies and build sustainable US-based pharmaceutical and biopharmaceutical manufacturing
• Monitor KPIs related to adoption, customer satisfaction, and contribution to USP’s 2030 commitments

Senior Scientist I, Technical Support Compounding

Senior Digital Standards Policy and Implementation Manager

Senior Digital Standards and Industry Solutions Manager

Product and Market Development Director