Senior Director, Advanced Manufacturing & Tech Strategy

BioSpace; Rockville (MD); On-site; USD 206,000 - 292,000; Full time

Job summary

U.S. Pharmacopeial Convention (USP) in Rockville, MD, seeks a Senior Director, Technology Development & Strategic Programs to lead advanced pharmaceutical manufacturing and analytical technology initiatives.

You will build and direct multidisciplinary programs, translate needs into technical roadmaps, and drive demonstrations from concept to transition. This leadership role requires 12+ years in complex science/engineering programs, strong executive communication, and a track record of

Qualifications

• Bachelor’s degree in a relevant scientific, engineering, computing, or quantitative discipline.
• 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 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.
• 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.

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.

Skills

Leadership experience

Executive communication

Cross-functional collaboration

AI/ML depth

Systems thinking

Program management

Education

Bachelor’s degree in relevant field

Advanced degree preferred

Job description

U.S. Pharmacopeial Convention (USP) in Rockville, MD, seeks a Senior Director, Technology Development & Strategic Programs to lead advanced pharmaceutical manufacturing and analytical technology initiatives.

You will build and direct multidisciplinary programs, translate needs into technical roadmaps, and drive demonstrations from concept to transition. This leadership role requires 12+ years in complex science/engineering programs, strong executive communication, and a track record of