Senior CMC Technical Advisor (Kenya)

SOKIFY PRESENTS: Senior CMC Technical Advisor (Kenya) with United States Pharmacopeia ABOUT UNITED STATES PHARMACOPEIA The U.S. Pharmacopeial Convention is an independent scientific organization partnering with global health and science leaders to establish rigorous quality standards for medicines, dietary supplements, and food ingredients. Driven by a commitment to fairness, integrity, and collaboration, USP employs over 1,300 professionals across twenty worldwide locations dedicated to strengthening the supply of safe, high-quality medicines globally. USP champions inclusive scientific collaboration, recognizing that diverse expertise strengthens standard development and public health outcomes. The organization provides equitable access to mentorship, professional development, and leadership opportunities, fostering a culture of inclusive collaboration. As an equal employment opportunity employer, USP ensures merit-based selection processes enabling talented professionals from all backgrounds to advance public health solutions worldwide. POSITION OVERVIEW USP is recruiting a Senior CMC Technical Advisor to strengthen manufacturing competencies and capabilities in the medical products sector. You will deliver technical assistance and oversight to manufacturers and regulators, working toward the critical goal of expanding access to quality-assured essential medical products. This role involves cross-departmental collaboration within USP alongside direct engagement with pharmaceutical manufacturers and regulatory bodies. YOUR IMPACT In advancing USP's mission of scientific rigor and public health standards, you will drive global access to high-quality medicines through public standards and complementary programs. You will emphasize scientific integrity, regulatory excellence, and evidence-based decision-making, ensuring health systems worldwide benefit from strong, tested, and internationally relevant quality standards. KEY RESPONSIBILITIES Lead comprehensive GMP audits and provide technical guidance to manufacturers in technology transfer, dossier development, and compliance with WHO PQ, PIC/S, and EC standards using training and best-practice tools. Develop technical documents and practical tools supporting localization of medical product manufacturing across low and middle-income countries. Identify potential CMC risks, design mitigation strategies, and establish contingency plans to maintain project momentum. Execute compliance audits aligned with WHO Prequalification and international standards, guiding manufacturers through corrective action implementation and compliance strategies. Build public-private partnerships strengthening regional manufacturing ecosystems and improving pharmaceutical quality access. Work across teams to develop and implement manufacturing strategies reflecting global best practices. Evaluate technical deliverables and donor reports with precision, ensuring accuracy and compliance requirements. Track global and regional manufacturing trends and regulatory developments with particular emphasis on Africa, sharing actionable insights internally. Represent USP at international manufacturing forums and contribute to shaping global policy conversations. Address additional CMC-related assignments as directed by leadership. REQUIRED QUALIFICATIONS Minimum 10 years of hands-on pharmaceutical manufacturing and process development experience. Demonstrated expertise in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and regulatory submission preparation. In-depth knowledge of WHO PQ, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards. Strong comprehension of CMC principles and GMP requirements across medicines, packaging, and related domains. Documented experience navigating regulatory authority registration procedures. Exceptional technical writing abilities and articulate oral communication skills for producing high-quality documentation. Capacity to travel up to 25% annually. PREFERRED ATTRIBUTES Experience within at least one health area including HIV/AIDS, malaria, or maternal and neonatal child health. Practical experience with critical manufacturing systems including water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development. Comprehensive understanding of global market dynamics and supply chain challenges affecting pharmaceutical and medical product access. Hands-on involvement with WHO Prequalification programs and international regulatory pathways. Current location in Kenya, though qualified regional candidates are welcome. POSITION DETAILS This is a full-time, non-supervisory position operating as an individual contributor role with no direct reports. USP provides comprehensive benefits protecting personal and family wellbeing, including company-paid time off, comprehensive healthcare coverage, and retirement savings options. Sokify is not responsible for recruitment agency fees except under specific written agreement with USP. Unsolicited resumes from third-party recruitment agencies are not accepted.