Director, Digital Reference Standards Products – Partnerships

🔥 12 hours ago

🏄 California, District of Columbia, +10 more states – Remote

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💵 $171.8k - $243.3k / year

⏰ Full Time

🔴 Lead

💰 Account Manager

👻 Ghost score 0%

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Logo of US Pharmacopeia

US Pharmacopeia

1001 - 5000 employees

Founded 1820

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

US Pharmacopeia is a non-profit scientific organization that develops and publishes public quality standards, reference materials, and analytical guidance for medicines, dietary supplements, and food ingredients to protect patient and consumer safety worldwide. USP provides over 7,000 reference standards, verification and audit programs, training and technical guidance (including for biologics, gene therapies, and impurities), and data-driven tools to strengthen medicine supply chains and regulatory predictability.

📋 Description

• Own the strategy, development, delivery, and adoption of Digital Reference Standards products, including USP-ID • Define product vision, strategy, roadmap, target use cases, value proposition, success measures, and investment recommendations • Convert customer observations, validation findings, scientific limitations, and regulatory expectations into requirements, acceptance criteria, development priorities, and evidence plans • Manage software development and integration roadmaps, backlog prioritization, release planning, user acceptance testing, defect resolution, documentation, knowledge transfer, and business continuity planning • Serve as the primary product-management counterpart for external developers, integration partners, distributors, and technical collaborators • Establish operating cadences, shared deliverables, decision rights, and escalation pathways with partners • Partner with Science and Quality on validation readiness, controlled documentation, traceability, risk assessment, remediation planning, and product claims • Lead customer discovery, lighthouse collaborations, demonstrations, trials, onboarding, support escalation, and post-trial learning • Lead pricing, packaging, channel strategy, forecasts, budgets, contracts, licensing arrangements, and partner economics • Support governance through executive updates, KPI and risk reviews, decision documentation, and product and partner knowledge repositories • Contribute product perspectives to the Digital Standards strategy and scientific framework • Provide functional leadership across scientific, quality, technology, marketing, commercial, and external partner contributors • Supervise the Program Manager, Digital Standards

🎯 Requirements

• Bachelor's degree in analytical chemistry, chemistry, chemical engineering, pharmaceutical sciences, cheminformatics, scientific computing, or a related discipline • Ten or more years of relevant professional experience, including substantial responsibility for scientific software, digital laboratory products, analytical technologies, or regulated life science product development or customer acquisition • Experience identifying and articulating customer needs and product-market fit in a scientific software context • Experience translating customer needs into software requirements, acceptance criteria, and roadmap decisions • Experience managing external software development, technology, distribution, or commercialization partners • Experience coordinating across scientific, quality, legal, commercial, and executive stakeholders in a matrixed organization • Working knowledge of analytical laboratory workflows and performance concepts including accuracy, precision, reproducibility, robustness, traceability, and fitness for purpose • Ability to explain technical risks, evidence gaps, and strategic choices to non-specialists • Demonstrated judgment in identifying, documenting, and escalating product, supplier, quality, architectural, and commercial risks • Remote employees must reside in MD, VA, DC, PA, WV, CA, MI, IL, KS, FL, NC, or MN • Desired: Master's degree, PhD, PharmD, or MBA • Desired: Hands-on NMR or qNMR experience, or knowledge of quantum mechanical spectral analysis, chemometrics, spectral informatics, or scientific model libraries • Desired: At least four years of product management or product owner experience • Desired: Experience developing or commercializing software for pharmaceutical R&D, analytical development, process chemistry, manufacturing, or quality control • Desired: Experience with software used in GxP or other regulated environments, including electronic records, audit trails, user permissions, validation documentation, change control, or 21 CFR Part 11 • Desired: Experience operationalizing licensing, distribution, co-development, intellectual property, or strategic partnership agreements • Desired: Experience in a standard setting organization, regulatory agency, pharmaceutical company, scientific software company, analytical instrument company, or laboratory informatics business

🏖️ Benefits

• Company paid time off • Comprehensive healthcare options • Retirement savings • Target annual bonus (percentage varies based on level of role)

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