Senior CMC Technical Advisor

ABOUT THE COMPANY

For health standards

JOB SUMMARY

RequirementsThe 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.

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.

REQUIRED SKILLS

Leadership skills, Public Relations, Business management, Business development, Operative planning, Partnerships

REQUIRED EDUCATION

Diploma, Associate's degree