Brief Job Overview
USP is in search of a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The selected candidate will deliver technical guidance and supervision to manufacturers and regulatory bodies to ensure the production of quality-assured essential medical products. This role involves collaboration with internal USP teams, medical product manufacturers, and regulatory agencies.
How will you drive meaningful contributions within our organization at USP?
You will contribute significantly to our commitment to advancing scientific rigor and public health standards by facilitating broader access to high-quality medicines through public standards and associated initiatives. USP upholds scientific integrity, regulatory excellence, and evidence-based decision-making to guarantee that health systems globally can depend on robust, validated, and internationally applicable quality standards.
Additionally, USP’s People and Culture division collaborates with the Equity Office to foster leadership and workforce development initiatives aimed at empowering every employee with the competencies needed to cultivate high-performing, inclusive teams. These efforts encompass targeted training in equitable management strategies and practical tools designed to cultivate engaged, collaborative, and results-oriented work environments.
Responsibilities
The Senior CMC Technical Advisor is responsible for overseeing critical aspects of Chemical, Manufacturing, and Controls (CMC) development, ensuring compliance with regulatory standards and technical excellence. This role involves providing expert guidance on CMC strategies, addressing complex technical challenges, and collaborating with cross-functional teams to advance drug development programs. Responsibilities include leading CMC due diligence for in-licensing opportunities, evaluating manufacturing processes, and supporting regulatory submissions. The position requires a deep understanding of CMC principles, strong problem-solving skills, and the ability to mentor junior team members while driving innovation in process development and lifecycle management.
Lead Good Manufacturing Practice audits and deliver specialized guidance to manufacturers regarding technology transfer, dossier compilation, and adherence to WHO Prequalification, PIC/S, and European Commission regulatory standards through targeted training sessions and implementation of industry-leading best-practice methodologies.
Compose technical documentation and create tools to facilitate the localization of medical product manufacturing in low- and middle-income countries.
Conduct a thorough risk assessment of CMC (Chemistry, Manufacturing, and Controls) factors and develop robust mitigation strategies alongside contingency plans to safeguard uninterrupted project progression.
Conduct compliance audits in accordance with WHO Prequalification criteria and additional international standards, while providing manufacturers with guidance on corrective measures and compliance frameworks.
Drive strategic collaborations between public and private entities to enhance regional manufacturing ecosystems and broaden access to high-quality pharmaceuticals.
Partner with diverse internal teams to develop and execute manufacturing strategies in accordance with globally recognized best practices.
Evaluate technical deliverables and donor reports promptly, ensuring precision and adherence to compliance standards while delivering high-quality feedback.
Monitor global and regional manufacturing trends, with particular emphasis on Africa, while staying updated on regulatory requirements, and relay these insights to relevant internal teams.
Represent USP in international manufacturing forums and engage in the formulation of global policy discussions.
Execute assigned CMC-related responsibilities as directed by leadership to advance program goals.
USP is seeking a dynamic professional to join its team, with a keen eye for detail and a commitment to excellence. The ideal candidate will possess a strong foundation in [relevant field or industry], supported by [specific education or certification, if applicable]. Proficiency in [specific skills or tools] is required, along with the ability to [key responsibility or task]. Candidates should demonstrate adaptability in [specific context or scenario], ensuring seamless integration into USP’s collaborative environment. Experience in [related experience] and a dedication to [specific value or goal] will be highly advantageous. USP values individuals who thrive in a fast-paced setting while maintaining the highest standards of quality and integrity.
The ideal candidate will exhibit a clear grasp of our mission, embody a dedication to excellence through inclusive and equitable behaviors and practices, and possess the capacity to swiftly establish trust with stakeholders, in addition to fulfilling the following competencies and experience.
Execute any supplementary CMC activities designated by management to further program goals.
A decade or more of practical experience in pharmaceutical manufacturing and process development is required.
Experienced professional with strong proficiency in manufacturing operations, including conducting comparability and feasibility assessments, implementing stability programs, advancing analytical methodologies, and compiling comprehensive regulatory submissions.
Possesses comprehensive expertise in WHO Prequalification (PQ) processes, PIC/S guidelines, WHO Technical Report Series, European Commission (EC) specifications, and UNICEF technical standards.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) standards applicable to pharmaceuticals, packaging, and associated processes is essential.
Proven track record in managing regulatory authority registration processes effectively.
Proficient in crafting clear, precise technical documentation and delivering compelling verbal presentations, ensuring the development of top-tier materials.
Able to travel up to 25% of the time, with both readiness and capacity to fulfill such requirements.
Additional Desired Preferences
Preferred qualifications are welcomed to highlight any supplementary areas of expertise relevant to the role. Kindly note that items included in this section do not constitute mandatory requirements or serve as grounds for exclusion from consideration.
Proficiency in at least one of these specialized health domains is required: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Applicants should possess hands-on experience with essential manufacturing systems and processes—such as water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development.
Proven expertise in analyzing global market trends and supply chain complexities that influence the availability of high-quality, assured pharmaceuticals and medical products.
Proven expertise in navigating WHO Prequalification programs and other internationally recognized regulatory pathways is required.
A strong preference exists for candidates based in Kenya; however, qualified professionals from neighboring countries within the region are also encouraged to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
