BioSpace
Project Director: Pharmaceutical Stability and Climate Resilience (Hybrid)
BioSpace, Rockville, Maryland, us, 20849
Project Director: Pharmaceutical Stability and Climate Resilience (Hybrid)
BioSpace
Join us as a Project Director to lead an international partnership addressing heat‑stability challenges for critical health products under climate‑change scenarios.
Brief Project Director Overview The Project Director will lead the implementation of a multi‑country award, providing strategic leadership, technical expertise, and oversight of program performance. The role includes liaison with stakeholders, ensuring compliance with regulations, and establishing systems to demonstrate progress.
How you create impact In this role you contribute to USP’s public health mission, expanding equitable access to high‑quality medicines and improving global health. USP invests in professional development and inclusive management practices.
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 countries.
Guide evidence generation with direct linkages to community health impacts and ensure rigorous research methodologies meet international standards.
Build and maintain partnerships with country stakeholders, including governments, community organizations, and global health agencies.
Provide technical thought leadership to identify, evaluate, and prioritize heat‑resilient product innovations, especially from the Global South.
Oversee early‑stage investments and proof‑of‑concept pilots.
Ensure timely development and dissemination of evidence‑based knowledge products for global stakeholders.
Who is USP looking for?
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.
Experience in implementation research and evidence generation for health products.
Deep expertise in pharmaceutical lifecycle management and real‑world product performance monitoring.
Experience with 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.
Additional Desired Preferences
Familiarity with Unitaids priority disease areas and decentralized care models.
Supervisory Responsibilities The Project Director will directly supervise project staff; the number of direct reports is to be determined.
Equal Opportunity Employer USP is an equal employment opportunity employer and affirmative action employer. We are committed to creating an inclusive environment and providing reasonable accommodation to individuals with disabilities.
Job Category Sales & Marketing
Job Type Full‑Time
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Join us as a Project Director to lead an international partnership addressing heat‑stability challenges for critical health products under climate‑change scenarios.
Brief Project Director Overview The Project Director will lead the implementation of a multi‑country award, providing strategic leadership, technical expertise, and oversight of program performance. The role includes liaison with stakeholders, ensuring compliance with regulations, and establishing systems to demonstrate progress.
How you create impact In this role you contribute to USP’s public health mission, expanding equitable access to high‑quality medicines and improving global health. USP invests in professional development and inclusive management practices.
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 countries.
Guide evidence generation with direct linkages to community health impacts and ensure rigorous research methodologies meet international standards.
Build and maintain partnerships with country stakeholders, including governments, community organizations, and global health agencies.
Provide technical thought leadership to identify, evaluate, and prioritize heat‑resilient product innovations, especially from the Global South.
Oversee early‑stage investments and proof‑of‑concept pilots.
Ensure timely development and dissemination of evidence‑based knowledge products for global stakeholders.
Who is USP looking for?
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.
Experience in implementation research and evidence generation for health products.
Deep expertise in pharmaceutical lifecycle management and real‑world product performance monitoring.
Experience with 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.
Additional Desired Preferences
Familiarity with Unitaids priority disease areas and decentralized care models.
Supervisory Responsibilities The Project Director will directly supervise project staff; the number of direct reports is to be determined.
Equal Opportunity Employer USP is an equal employment opportunity employer and affirmative action employer. We are committed to creating an inclusive environment and providing reasonable accommodation to individuals with disabilities.
Job Category Sales & Marketing
Job Type Full‑Time
#J-18808-Ljbffr