Project Director – Pharmaceutical Stability, Climate Resilience
US Pharmacopeia
full-time
Posted on:
Location Type: Hybrid
Location: Rockville • Maryland • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Lead the implementation of an anticipated multi-country award to investigate and address heat-stability challenges for critical health products under climate-change scenarios.
- Provide strategic leadership, technical expertise, and complete oversight of program performance, ensuring timely delivery of high-quality project deliverables.
- Serve as the primary liaison with key stakeholders, ensuring synergy with existing programs and initiatives.
- Ensure effective delivery across all goals, objectives, and strategies, in compliance with applicable regulations, policies, and procedures.
- Establish systems that demonstrate program progress and achievements.
- Direct and supervise the project team by leveraging effective leadership and management skills.
Requirements
- 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.
Benefits
- Equal employment opportunity employer (EEOE)
- Commitment to creating an inclusive environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmaceutical stabilityregulatory complianceproduct lifecycle managementstability testing protocolsstability data managementautomated systems for stability trackingimplementation researchreal-world product performance monitoringICH stability guidelinesanalytical methods
Soft skills
strategic leadershipproject managementstakeholder engagementcommunicationnegotiationcross-cultural collaborationteam supervisionorganizational skillseffective deliverysynergy facilitation