We are seeking a highly motivated candidate to fill the position with [Job Title], responsible for overseeing key operational tasks and ensuring seamless team collaboration. The ideal applicant will possess a Bachelor’s degree in [Relevant Field] or a related discipline, along with [X] years of professional experience in [Industry/Sector]. Strong proficiency in [Software/Tool] and expertise in [Specific Skill] are essential, while familiarity with [Additional Requirement] is highly desirable. The role involves managing [Key Responsibility 1], coordinating [Key Responsibility 2], and contributing to [Key Responsibility 3], all while maintaining strict adherence to company policies and industry regulations. Exceptional problem-solving abilities, clear communication skills, and a results-driven mindset are critical for success in this position.
USP is actively recruiting for a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The selected candidate will deliver expert technical guidance and supervision to manufacturers and regulatory bodies, ensuring the attainment of key objectives—namely, bolstering the supply of high-quality, essential medical products. Additionally, the role involves collaborating with internal USP teams, external medical product manufacturers, and regulatory agencies.
How will you contribute to our mission and drive meaningful change at USP?
In this role, you will significantly contribute to our efforts to enhance scientific rigor and public health standards by broadening global access to high-quality medications through our public standards and associated initiatives. At USP, we uphold uncompromising scientific integrity, regulatory excellence, and evidence-based decision-making to foster health systems that depend on robust, validated, and internationally applicable quality standards.
Furthermore, the People and Culture division of USP collaborates with the Equity Office to cultivate leadership and workforce capabilities, ensuring all employees are prepared to cultivate high-performing, inclusive teams. This effort encompasses equitable management training and the implementation of tools designed to foster engagement, collaboration, and measurable outcomes.
Responsibilities
The Senior CMC Technical Advisor is tasked with overseeing and providing expert guidance on all aspects of CMC (Chemistry, Manufacturing, and Controls) development, ensuring compliance with regulatory standards and alignment with project goals. Responsibilities include leading technical teams, resolving complex CMC challenges, and collaborating closely with cross-functional stakeholders to optimize manufacturing processes. Additionally, the role entails reviewing and approving CMC documentation, conducting risk assessments, and advising on strategic decisions to support successful product development and regulatory submissions.
Conduct GMP audits and deliver expert technical guidance to manufacturers regarding technology transfer, dossier preparation, and adherence to WHO PQ, PIC/S, and EC standards through targeted training sessions and the implementation of industry-leading best-practice tools.
Create technical documentation and resources to facilitate the localization of medical product manufacturing processes in low- and middle-income countries (Mics).
Ascertain CMC risks and develop mitigation strategies alongside contingency plans to safeguard project continuity.
Conduct compliance audits in alignment with WHO Prequalification criteria and additional international standards, providing manufacturers with guidance on implementing corrective measures and developing compliance strategies.
Develop and nurture collaborations between public and private sectors to enhance regional manufacturing infrastructure and ensure equitable access to high-quality pharmaceutical products.
Partner with interdisciplinary teams to develop and execute manufacturing strategies that adhere to internationally recognized best practices.
Evaluate technical deliverables and donor reports promptly to deliver accurate, compliant submissions of the highest quality.
Monitor global and regional manufacturing trends and regulatory requirements, particularly within Africa, and disseminate these insights to internal stakeholders.
Represent USP in international manufacturing forums and engage in influential discussions to help shape global policy.
Execute supplementary CMC-related assignments as directed by management to advance program goals.
USP is seeking qualified candidates who demonstrate a strong alignment with our organizational values and mission. Ideal applicants will possess the requisite skills and experience to excel in their designated roles while contributing effectively to our team’s success. The position requires meticulous attention to detail, a proactive approach to problem-solving, and the ability to collaborate seamlessly within a dynamic work environment. Candidates should exhibit a commitment to continuous learning and professional growth to drive innovation and operational excellence.
The ideal candidate will exhibit a clear comprehension of our mission and an unwavering dedication to excellence, fostering an environment of inclusivity and equity through both behavior and practice. They must possess the skill to rapidly establish trust and credibility with stakeholders while demonstrating the following competencies and professional experience.
Execute supplementary CMC-related duties as designated by senior management to advance program goals.
A decade or more of practical experience in pharmaceutical manufacturing and process development is essential.
Extensive experience in manufacturing processes, comparative analyses, feasibility assessments, stability program management, analytical method development, and preparation of regulatory documentation.
Possesses comprehensive expertise in WHO Prequalification (PQ), PIC/S guidelines, WHO Technical Report Series, European Commission (EC) specifications, and UNICEF technical benchmarks.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) regulations governing pharmaceuticals, packaging, and ancillary processes is essential.
Successfully managed and completed regulatory authority registration processes through practical application.
Requires outstanding technical writing and verbal communication abilities, capable of delivering superior documentation.
Able to travel up to 25% of the time, with a willingness and capacity to do so.
Additional Desired Preferences
Preferred qualifications include the opportunity to highlight supplementary proficiency levels relevant to the position. It is important to note that the items listed in this section do not serve as mandatory criteria nor do they exclude candidates from consideration.
Professional experience in at least one of these specialized health domains is required: HIV/AIDS, malaria, or MNCH.
Proficiency in operating essential manufacturing systems and processes is required, such as water systems, sterility assurance protocols, HVAC systems, contamination control measures, analytical chemistry techniques, cleaning validation procedures, and formulation development methodologies.
Profound knowledge of worldwide market conditions and supply chain complexities that impact the availability of quality-certified pharmaceuticals and medical products.
Proficiency in navigating WHO Prequalification programs and other international regulatory frameworks is essential.
Preferred locations include Kenya, though applicants from other countries within the region are also welcome to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
