US Pharmacopeia ยท 1 day ago
Project Director: Pharmaceutical Stability and Climate Resilience (Hybrid)
Rockville, MD
Contract
Hybrid
Director/Executive
10+ years expThe U.S. Pharmacopeial Convention (USP) is an independent scientific organization that develops quality standards for health products. The Project Director will lead the implementation of a multi-country project to address heat-stability challenges for health products under climate-change scenarios, providing strategic leadership and oversight of program performance.
MedicalNon ProfitPharmaceuticalPublishing
Responsibilities
Oversee all technical and management leadership for each project phase: evidence generation, solution mapping, and innovation advancement
Oversee assessment of heat and humidity impacts on health products across their entire lifecycle for multiple products and across multiple countries
Guide evidence generation with direct linkages to community health impacts and ensure robust research methodologies meet international standards
Build and maintain partnerships with country stakeholders, including governments, community organizations, global health agencies, and others
Provide technical thought leadership and expertise to identify, evaluate, and prioritize heat-resilient product innovations, especially from the Global South, and to develop pathways for the scalability and sustainability of interventions
Oversee early-stage investments and proof-of-concept pilots
Ensure timely development and dissemination of evidence-based knowledge products for global stakeholders
Qualification
Required
Advanced degree in Pharmaceutical Sciences, Chemistry, Public Health, or related field
10+ years of experience in pharmaceutical stability, regulatory compliance, and product lifecycle management
Proven track record of developing stability testing protocols, managing stability data for regulatory submissions, and implementing automated systems for stability tracking and analysis
Proven track record in implementation research and evidence generation for health products
Deep expertise in pharmaceutical lifecycle management and real-world product performance monitoring
Proven track record in global health programs and multi-country project leadership
Expertise in ICH stability guidelines, GMP/cGMP frameworks, and analytical methods
Strong understanding of climate-related risks to health products and supply chains
Experience with consortium management, stakeholder engagement, and donor-funded projects
Working experience in LMICs
Demonstrated ability to manage large and complex global projects
Excellent communication, negotiation, and cross-cultural collaboration skills
Preferred
Advanced degree in Pharmaceutical Sciences, Chemistry, Public Health, or related field
Familiarity with Unitaid's priority disease areas and decentralized care models
Company
US Pharmacopeia
US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820.
1001-5000 employees
H1B Sponsorship
US Pharmacopeia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ronald Piervincenzi
Chief Executive Officer
Stan Burhans
SVP Operations and Chief Financial Officer
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