Senior CMC Technical Advisor at U.S. Pharmacopeial Convention (USP)

The Senior CMC Technical Advisor has the following responsibilities:

• Lead GMP audits and provide technical assistance to manufacturers on technology transfer, dossier development, and compliance with WHO PQ, PIC/S, and EC standards through training and deployment of best-practice tools.
• Develop technical documents and tools to support localization of medical product manufacturing in LMICs.
• Identify CMC risks and design mitigation strategies and contingency plans to ensure project continuity.
• Conduct compliance audits aligned with WHO Prequalification and other international standards; guide manufacturers in implementing corrective actions and compliance strategies.
• Facilitate public-private partnerships to strengthen regional manufacturing ecosystems and improve access to quality pharmaceuticals.
• Collaborate with cross-functional teams to design and implement manufacturing strategies that align with global best practices.
• Review and provide timely, high-quality input on technical deliverables and donor reports to ensure accuracy and compliance.
• Monitor global and regional manufacturing trends and regulatory requirements, with a focus on Africa, and share insights with internal teams.
• Represent USP in international manufacturing forums and contribute to shaping global policy discussions.
• Perform additional CMC-related tasks as assigned by leadership to support program objectives.

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:
• Perform additional CMC-related tasks as assigned by leadership to support program objectives.
• Minimum of 10 years of hands-on experience in pharmaceutical manufacturing and process development.
• Proven expertise in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and preparation of regulatory submissions.
• In-depth knowledge of WHO PQ, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards.
• Comprehensive understanding of CMC principles and GMP requirements for medicines, packaging, and related areas.
• Demonstrated experience navigating regulatory authority registration processes.
• Exceptional technical writing and oral communication skills, with ability to produce high-quality documentation.
• Willingness and ability to travel up to 25% of the time.