Brief Job Overview
USP is currently searching for a Senior CMC Technical Advisor to enhance expertise and operational capacity in the manufacturing of medical products. The selected candidate will deliver expert technical support and supervision to manufacturers and regulatory bodies, ensuring the successful attainment of increased supply for essential medical products that meet high-quality standards. The individual will collaborate closely with internal USP teams, as well as external stakeholders, including medical product manufacturers and regulatory authorities.
How will you contribute to meaningful change and drive impactful outcomes in your role at USP?
You will contribute significantly to our mission of enhancing scientific rigor and public health standards by facilitating broader global access to medicines of the highest quality through public standards and affiliated initiatives. USP upholds scientific integrity, regulatory excellence, and data-driven decision-making to guarantee that health systems globally can depend on robust, validated, and internationally applicable quality standards.
USP’s People and Culture division collaborates with the Equity Office to cultivate leadership and workforce capabilities, ensuring every employee gains the competencies necessary to build high-performing, inclusive teams. The initiative encompasses targeted training in equitable management strategies and practical tools designed to foster engaged, collaborative, and results-oriented work environments.
Develops, implements, and monitors strategic initiatives to enhance organizational performance. Oversees daily operations to ensure alignment with company objectives and regulatory compliance. Leads and motivates cross-functional teams to achieve departmental goals efficiently. Collaborates with senior leadership to drive innovation and continuous improvement across processes. Manages budgets, allocates resources, and tracks expenditures to optimize financial outcomes. Identifies risks, implements mitigation strategies, and ensures adherence to industry standards.
The Senior CMC Technical Advisor is responsible for overseeing and providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) activities throughout the product development lifecycle. This role entails ensuring compliance with regulatory standards, addressing technical challenges, and supporting the successful progression of drug candidates from early-stage development through commercialization. Key duties include collaborating with cross-functional teams to develop robust manufacturing processes, optimizing formulations, and maintaining high-quality standards in line with Good Manufacturing Practices (GMP). Additionally, the advisor plays a critical role in preparing and reviewing CMC documentation for regulatory submissions, identifying potential risks, and implementing mitigation strategies to support timely approvals. Strong leadership and communication skills are essential to drive alignment across stakeholders and uphold the integrity of CMC regulatory strategies.
Conduct Good Manufacturing Practice (GMP) audits and deliver specialized technical guidance to manufacturers regarding technology transfer initiatives, dossier preparation, and adherence to WHO Prequalification (PQ), PIC/S, and European Commission (EC) standards, facilitated through targeted training sessions and the implementation of industry-leading best practices.
Prepare comprehensive technical documents and create specialized tools to facilitate the localization of medical product manufacturing within low- and middle-income countries (Mics).
Identify potential risks in Chemistry, Manufacturing, and Controls (CMC) and develop mitigation strategies along with contingency plans to safeguard project continuity.
Perform compliance audits in accordance with WHO Prequalification criteria and other internationally recognized standards, while providing manufacturers with guidance on implementing corrective actions and developing robust compliance strategies.
Foster collaborative alliances between public and private sectors to enhance regional manufacturing ecosystems and expand access to high-quality pharmaceuticals.
Partner with diverse teams across the organization to develop and execute manufacturing strategies that adhere to internationally recognized best practices.
Evaluate technical deliverables and donor reports promptly, delivering meticulous feedback to uphold accuracy and ensure full compliance with established standards.
Monitor global and regional manufacturing developments while staying abreast of regulatory frameworks, with particular emphasis on African markets, and disseminate findings to relevant internal stakeholders.
As a representative of USP, engage in international manufacturing forums to actively participate in the development and influence of global policy discussions.
Execute supplementary CMC-related assignments as directed by management to advance program objectives.
USP is seeking candidates who demonstrate a strong alignment with our mission and values. We prioritize individuals who possess the necessary qualifications, skills, and experience to excel in this role. Ideal applicants will meet all specified job requirements and bring a proactive approach to fulfilling their responsibilities. Proficiency in relevant tools, methodologies, and industry standards is essential, along with the ability to collaborate effectively within a team-oriented environment.
The ideal candidate will demonstrate a thorough grasp of our mission, uphold a commitment to excellence through inclusive and equitable behaviors and practices, and swiftly establish trust and credibility with stakeholders. Additionally, they will possess the following competencies and experience.
Execute supplementary CMC-related assignments as directed by management to advance program goals.
A decade or more of practical engagement in pharmaceutical manufacturing and process development is essential.
Seasoned professional with a strong track record in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and the preparation of regulatory submissions.
Proficient understanding of WHO Prequalification (PQ) criteria, PIC/S guidelines, WHO Technical Report Series, European Pharmacopoeia (Ph. Eur.) specifications, and UNICEF procurement and technical standards is required.
Profound knowledge of Chemistry, Manufacturing, and Controls (CMC) principles alongside Good Manufacturing Practice (GMP) regulations governing pharmaceuticals, packaging, and associated domains is essential.
Proven expertise in managing and completing regulatory authority registration procedures.
High-level proficiency in both technical writing and verbal communication is required, enabling the creation of meticulously crafted documentation.
Capable of accommodating travel commitments amounting to up to 25% of total work time, ensuring flexibility and availability for business-related journeys as required.
Additional Desired Preferences
Desired preferences include demonstrating any additional levels of expertise that would enhance performance in this role. Please note that items listed in this section are neither mandatory requirements nor grounds for disqualification from consideration.
Proficiency in one or more of the following health domains is required: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Proficiency in operating and optimizing essential manufacturing systems and processes is required, encompassing water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development.
Profound knowledge of worldwide market trends and supply chain complexities that impact the availability of high-quality, assured pharmaceuticals and medical products is essential.
Possesses practical expertise in navigating WHO Prequalification programs and other international regulatory frameworks.
While a Kenyan location is preferred, candidates from other regional countries demonstrating suitability are strongly encouraged to apply.
Qualifications
BA/BSc/HND
Experience Required
10 years
