The position offers a concise overview of key responsibilities and essential qualifications for applicants to quickly grasp the role’s core functions and necessary competencies. It highlights critical requirements and primary duties to ensure candidates understand the expectations and required skills upfront. The summary serves as an initial screening tool, allowing both the employer and potential applicants to assess alignment with the role’s demands efficiently.
USP is recruiting a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The selected professional will deliver technical guidance and supervision to manufacturers and regulatory bodies to meet the goal of boosting the availability of high-quality essential medical products. Additionally, the role will involve collaboration with internal USP teams as well as external stakeholders, including medical product manufacturers and regulatory authorities.
How will you drive meaningful change and contribute to the mission of USP in this role?
In alignment with our commitment to upholding scientific rigor and elevating public health standards, you will serve as a key contributor to expanding worldwide availability of high-quality pharmaceuticals through our public standards and associated initiatives. USP is dedicated to fostering scientific integrity, achieving regulatory excellence, and implementing decisions grounded in evidence to ensure 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 foster leadership and workforce growth, empowering employees with the competencies needed to cultivate high-performing, inclusive teams. This initiative encompasses equitable management training and the implementation of tools designed to foster engagement, collaboration, and results-driven outcomes.
Oversee a wide range of duties encompassing project management, team leadership, and strategic planning to ensure seamless operations and adherence to organizational objectives. Collaborate with cross-functional teams to identify opportunities for improvement, streamline processes, and enhance productivity across departments. Lead initiatives focused on innovation, efficiency, and quality assurance while maintaining rigorous compliance with industry standards and regulatory requirements. Prepare comprehensive reports, analyze performance metrics, and present actionable insights to senior leadership to support data-driven decision-making. Foster a culture of accountability, continuous development, and professional growth among team members through coaching, mentorship, and constructive feedback.
The Senior CMC Technical Advisor is tasked with overseeing and providing expert guidance on all Chemistry, Manufacturing, and Controls (CMC) aspects throughout the product lifecycle. This role involves collaborating closely with cross-functional teams to ensure compliance with regulatory standards, including FDA, EMA, and ICH guidelines. Additionally, the Senior CMC Technical Advisor plays a pivotal role in developing and implementing robust CMC strategies, managing manufacturing process improvements, and maintaining high-quality standards from development through commercialization. Key duties also include addressing technical challenges, preparing and reviewing CMC documentation, and supporting regulatory submissions to facilitate successful product approvals and post-market compliance.
Lead GMP audits and guide manufacturers in technology transfer, dossier development, and adherence to WHO PQ, PIC/S, and EC standards by delivering training and implementing best-practice tools.
Create technical documentation and specialized tools to facilitate the localization of medical product manufacturing processes in low- and middle-income countries (Mics).
Identify potential CMC risks and develop mitigation strategies and contingency plans to safeguard project continuity.
Conduct compliance audits in accordance with WHO Prequalification criteria and other international regulatory benchmarks, while providing manufacturers with strategic guidance on corrective measures and compliance frameworks.
Collaborate with both public and private sector stakeholders to enhance regional manufacturing ecosystems and ensure greater accessibility to high-quality pharmaceutical products.
Partner with diverse teams across the organization to develop and execute manufacturing strategies grounded in globally recognized best practices.
Evaluate technical deliverables and donor reports promptly, delivering constructive feedback to uphold accuracy and adherence to compliance standards.
Analyze global and regional manufacturing trends, particularly within Africa, while staying updated on regulatory requirements, and then disseminate these insights to internal stakeholders.
Represent USP in global manufacturing forums, playing a key role in influencing international policy discussions.
Execute various CMC-related assignments as directed by management to advance program goals.
USP is seeking a highly motivated individual to join our team, possessing the requisite skills and experience to contribute effectively in this dynamic role. The ideal candidate will demonstrate a strong commitment to excellence, coupled with the ability to collaborate seamlessly within a fast-paced environment. USP values professionals who exhibit initiative, adaptability, and a passion for achieving measurable results while upholding the highest standards of integrity and accountability.
The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
Execute supplementary CMC-related assignments as directed by management to further program goals.
A minimum of ten years of direct, practical experience in pharmaceutical manufacturing and process development is required.
Demonstrated proficiency in manufacturing processes, comparability and feasibility evaluations, stability program management, analytical development, and the preparation of regulatory submissions is essential.
Proficient in WHO Prequalification (PQ) processes, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards, with a comprehensive understanding of each.
A thorough knowledge of Chemistry, Manufacturing, and Controls (CMC) principles, along with Good Manufacturing Practice (GMP) requirements for pharmaceuticals, packaging, and associated fields, is essential.
Proven expertise in managing regulatory authority registration procedures is required.
Exceptional proficiency in technical writing and oral communication is required, along with the capacity to develop meticulously crafted documentation of the highest standard.
Capable and enthusiastic about traveling up to 25% of the time.
Additional Desired Preferences
Preferred qualifications are welcome to highlight any advanced skills that enhance the ability to execute the role effectively. Please note that items specified in this section do not constitute mandatory requirements nor exclude candidates from consideration.
Candidates must possess relevant experience in one or more of the following health sectors: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Proficiency is required in critical manufacturing systems and processes, such as water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development, with hands-on experience preferred.
Demonstrates a comprehensive grasp of worldwide market forces and supply chain complexities that influence the availability of high-quality, certified pharmaceuticals and medical products.
Proven expertise in engaging with WHO Prequalification programs and navigating alternative international regulatory pathways is essential.
A preference exists for candidates based in Kenya; however, highly qualified professionals from neighboring countries within the region are also strongly encouraged to apply.
Qualifications
BA/BSc/HND
Experience Required
10 years
