Brief Job Overview
USP is recruiting a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The successful candidate will deliver expert technical guidance and supervision to manufacturers and regulatory bodies, ensuring the production of high-quality essential medical products on a larger scale. The role involves active collaboration with internal USP teams, medical product manufacturers, and regulatory authorities.
How can you contribute meaningfully to our team and advance USP’s mission?
You will be instrumental in expanding global access to high-quality medicines by contributing to public standards and related initiatives, driven by USP’s commitment to scientific integrity, regulatory excellence, and evidence-based decision-making. This role ensures health systems worldwide can depend on robust, rigorously tested, and internationally relevant quality standards.
USP’s People and Culture division, in collaboration with the Equity Office, prioritizes leadership and workforce development initiatives to empower employees with the competencies needed for cultivating high-performing, inclusive teams. This encompasses training in equitable management practices and resources designed to foster engaged, collaborative, and results-oriented work environments.
Responsibilities
The Senior CMC Technical Advisor is responsible for overseeing and providing expert guidance on all Chemical, Manufacturing, and Controls (CMC) aspects throughout the drug development lifecycle, from early-stage research to commercial manufacturing. This role involves leading CMC strategy development, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to address technical challenges. Additionally, the Senior CMC Technical Advisor evaluates and mitigates risks associated with manufacturing processes, supports filings and inspections, and maintains alignment with Good Manufacturing Practices (GMP) and other applicable regulations. Strong leadership, extensive experience in CMC operations, and a deep understanding of regulatory expectations are essential for success in this position.
Lead Good Manufacturing Practices (GMP) audits while offering technical guidance to manufacturers regarding technology transfer, dossier compilation, and adherence to WHO Prequalification (PQ), PIC/S, and European Commission (EC) regulatory standards. Support these efforts through targeted training sessions and the implementation of industry-leading best-practice methodologies.
Prepare comprehensive technical documentation and design tools specifically to facilitate the localization of medical product manufacturing in low- and middle-income countries.
Assess CMC risks and develop mitigation strategies and contingency plans to safeguard project continuity.
Conduct compliance audits in accordance with WHO Prequalification criteria and other internationally recognized standards, while providing manufacturers with guidance on implementing corrective actions and compliance strategies.
Collaborate with public and private sectors to enhance regional manufacturing ecosystems and ensure improved availability of high-quality pharmaceuticals.
Partner with diverse teams across the organization to develop and execute manufacturing strategies that adhere to internationally recognized best practices.
Review technical deliverables and donor reports with precision and timeliness, offering constructive feedback to uphold accuracy and ensure compliance with established standards.
Monitor global and regional manufacturing trends alongside regulatory requirements, with particular emphasis on Africa, and disseminate these insights to internal stakeholders.
Represent USP in international manufacturing forums, actively engaging in global policy discourse to shape discussions and decisions.
Execute supplementary CMC-related assignments as directed by management to advance program goals.
USP is seeking a highly motivated professional who demonstrates a strong commitment to excellence and integrity. The ideal candidate will possess exceptional analytical skills and the ability to work effectively within a collaborative team environment. Proficiency in problem-solving and a keen attention to detail are essential for this role. Additionally, the candidate must meet all specified educational and experiential requirements to ensure alignment with the organization’s high standards.
The ideal candidate will exhibit a clear grasp of our organizational mission, demonstrate unwavering dedication to excellence through inclusive and equitable actions and policies, and possess the capacity to swiftly establish trust and credibility with stakeholders, in addition to the required competencies and professional experience.
Execute supplementary CMR-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.
Demonstrated proficiency in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and the preparation of regulatory submissions.
Proficient in WHO PQ, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards.
A thorough knowledge of Chemistry, Manufacturing, and Controls (CMC) principles alongside Good Manufacturing Practice (GMP) standards for pharmaceuticals, packaging, and associated disciplines is essential.
Experienced in successfully managing regulatory authority registration procedures.
Exceptional proficiency in technical writing and oral communication is required, enabling the creation of comprehensive and high-quality documentation.
Capable of traveling up to 25% of the time, with the flexibility to accommodate such arrangements when necessary.
Additional Desired Preferences
Preferred qualifications include opportunities to highlight advanced skills relevant to the position. Please note that items outlined in this section are neither mandatory nor do they serve as disqualifying factors in evaluating candidates.
Applicants should possess prior professional experience in at least one of the following critical health domains: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Proficiency in operating and optimizing critical manufacturing systems and processes, such as water systems, sterility assurance, HVAC systems, contamination control measures, analytical chemistry techniques, cleaning validation protocols, and formulation development methodologies, is required.
Seasoned expertise in navigating the complexities of global market forces and supply chain intricacies that directly influence the procurement and availability of high-quality, compliant pharmaceuticals and medical products.
Proficiency in navigating WHO Prequalification programs alongside other international regulatory frameworks is essential.
A strong preference exists for candidates based in Kenya; however, highly qualified professionals from neighboring countries within the region are also welcome to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
