Senior Director, Technology Development & Strategic Programs

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

Advances in manufacturing science, analytical technologies, automation, artificial intelligence, and digital systems are creating new opportunities to strengthen pharmaceutical manufacturing, medicine quality, and supply-chain resilience. Translating these advances into practical capabilities requires more than promising research. Technologies must be systematically developed, integrated, tested, validated, and prepared for implementation in real-world environments.

USP’s Advanced Manufacturing Technologies team develops technologies, strategic programs, and partnerships that address significant challenges in pharmaceutical manufacturing and quality.

The Senior Director, Technology Development & Strategic Programs will lead the development, maturation, integration, demonstration, validation, and transition of advanced pharmaceutical manufacturing and analytical technologies. The position will build and direct the multidisciplinary programs, technical partnerships, and organizational capabilities required to move priority technologies from concept toward operational use.

The Senior Director will translate customer, public-health, industry, and U.S. Government mission needs into technical requirements, development strategies, experimental programs, integrated demonstrations, and transition pathways. Programs may combine pharmaceutical science, manufacturing engineering, analytical technologies, instrumentation, automation, digital systems, data science, and artificial intelligence and machine learning. This will be accomplished through targeted USP investment, U.S. Government funding, and external partnerships. Upon award by ARPA-H FASTPaSS, the Senior Director will lead USP’s PHAROS Program (Pharmaceutical Holistic Authentication, Reference Intelligence, and Outcome Screening) through a consortium of ten organizations.

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 Director, Technology Development & Strategic Programs has the following responsibilities:

Lead Technology Development and Maturation: Own the progression of priority technologies from defined need through evidence-based development, integration, and demonstration.

• Translate customer, sponsor, public health, and manufacturing needs into technical requirements, performance targets, development roadmaps, and measurable success criteria.
• Lead iterative experimental development through design-build-test-learn cycles, prototypes, pilots, integration, and increasingly representative demonstrations.
• Apply systems thinking to integrate scientific, engineering, analytical, manufacturing, digital, and AI/ML technologies; resolve technical interfaces; and make evidence-based tradeoffs involving performance, cost, schedule, risk, scalability, and implementation.
• Contribute technical expertise as a subject matter expert as appropriate to each program.

Shape the Technology Development Portfolio: Recommend which technologies AMT should develop, where USP should invest, and when opportunities should advance, change direction, or stop.

• Identify significant pharmaceutical-manufacturing, analytical, medicine-quality, and supply-chain challenges that can be addressed through emerging technologies.
• Translate high-value needs and technology advances into defined development opportunities with clear use cases, intended outcomes, and implementation pathways.
• Evaluate opportunities based on strategic relevance, technical feasibility, differentiation, maturity, potential impact, resource requirements, funding potential, and pathway to use.
• Recommend targeted USP investment in feasibility studies, experimental development, prototypes, pilots, and demonstrations.
• Establish evidence-based development stages and recommend whether opportunities should advance, accelerate, pivot, partner, pause, transfer, or stop.

Lead Strategic R&D Programs: Own the integrated delivery of complex, high-priority technology-development programs that advance AMT and USP strategic priorities.

• Convert approved opportunities into executable multidisciplinary programs with clear objectives, workstreams, milestones, resources, governance, partner responsibilities, risks, deliverables, and measures of success.
• Lead internal and external teams to deliver the integrated technical outcome required by each program, while preserving clear scientific and technical ownership within individual disciplines.
• Maintain alignment among technical activities, resources, schedules, risks, sponsor commitments, and program outcomes through effective governance, decision-making, and partner accountability.
• Provide senior technical and programmatic leadership for U.S. Government and other externally funded programs, partnering with Business Development on sponsor and funding activities and Program Delivery on planning, controls, reporting, and delivery infrastructure.

Build Technology Capability and Partnerships: Build the scientific, engineering, organizational, and external capabilities required to execute AMT's technology-development portfolio.

• Identify capability gaps and build the scientific, engineering, infrastructure, data, methods, and technical capabilities required to execute AMT's technology-development portfolio.
• Determine which capabilities should reside within USP and which should be accessed through manufacturers, technology providers, universities, research organizations, government organizations, and other external partners.
• Build multidisciplinary technical partnerships and external ecosystems required to develop, demonstrate, scale, and transition complex technologies.
• Ensure that AMT programs create reusable methods, platforms, technical knowledge, data, and capabilities that strengthen USP's ability to execute future technology-development programs..

Scale, Validate, and Transition Technologies: Own technology development through demonstrated technical viability and transition readiness.

• Establish scale-up, verification, validation, implementation, and transition strategies appropriate to each technology, its intended use, and its downstream owner.
• Demonstrate technology performance under increasingly representative conditions and address barriers involving scale, manufacturability, robustness, reproducibility, usability, maintainability, operating complexity, and cost.
• Develop the technical evidence, documentation, and transfer package required for an identified manufacturer, government partner, USP function, or other downstream owner to assume responsibility.
• Transition mature capabilities toward deployment, continued development, USP products or services, licensing, external partnerships, or other sustainable models, and apply lessons learned to future technology and portfolio decisions.

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:

• Bachelor’s degree in relevant scientific, engineering, computing, or quantitative discipline, or an equivalent combination of education and experience.
• Minimum 12 years of relevant experience, including leadership of complex scientific, engineering, technology, or product-development programs.
• At least five years of accountable program, product, or technical leadership experience involving multiple workstreams, external partners, or matrixed teams.
• Technical depth in at least one of the following: AI/ML programming specific to pharmaceutical manufacturing and/or quality control; advanced, in-silico process modeling and/or chemometrics; non-destructive sensing technologies; advanced manufacturing modalities such as flow chemistry systems, continuous manufacturing, distributed manufacturing, or additive manufacturing of pharmaceuticals.
• Demonstrated ability to lead across organizational boundaries, make complex technical and programmatic tradeoffs, manage risk, and drive results.
• Strong executive, technical, written, and interpersonal communication skills.

Additional Desired Preferences

• Advanced degree in a relevant discipline.
• Demonstrated experience leading development or integration of a physical or digital-physical product/system, including prototype development, systems integration, verification/validation, and field or operational testing.
• Experience in pharmaceutical science, analytical technologies, compendial science, or regulatory science.
• Experience with systems engineering, hardware/software integration, requirements management, human factors, or field-deployable technology.
• Experience leading multi-institutional industry, academic, government, healthcare, or nonprofit partnerships.
• Experience with federally sponsored advanced technology programs such as ARPA-H, DARPA, BARDA, FDA, or DoD.
• Experience transitioning prototypes or pilot programs toward operational products or operations.

Supervisory Responsibilities

Provides direct and matrix leadership on all technology development programs in the senior director’s portfolio. Additional direct support staff will be added as the need develops.

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 $206,201.00 – $291,947.00 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.

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.