Brief Job Overview
USP is in search of an experienced Senior CMC Technical Advisor to enhance expertise and capabilities in the manufacturing of medical products. This role involves delivering specialized technical guidance and supervision to manufacturers and regulatory bodies to ensure the availability of high-quality essential medical products. The position requires collaboration with internal USP teams, medical product manufacturers, and regulatory authorities.
How will you drive meaningful contributions at USP?
You will contribute significantly to our mission of promoting scientific rigor and elevating public health standards by facilitating global access to high-quality medicines through the development and implementation of public standards and related initiatives. USP upholds a commitment to scientific integrity, regulatory excellence, and evidence-based decision-making, ensuring that health systems worldwide can depend on robust, rigorously tested, and globally applicable quality standards.
USP’s People and Culture division collaborates with the Equity Office to prioritize leadership and workforce development, empowering employees with essential skills to build high-performing, inclusive teams. The initiative encompasses training in equitable management practices and resources designed to foster engaged, collaborative, and results-oriented work environments.
Oversee a range of critical operational duties, ensuring efficient workflow management and adherence to established protocols. Develop and implement strategies to enhance productivity, streamline processes, and maintain high standards of quality across all assigned tasks. Collaborate with cross-functional teams to align objectives, resolve challenges, and drive continuous improvement initiatives. Monitor performance metrics, identify areas for optimization, and recommend data-driven solutions to support organizational goals. Maintain clear documentation, report progress to stakeholders, and ensure compliance with relevant policies and industry regulations. Foster a culture of accountability, professionalism, and innovation while mentoring team members to achieve collective success.
The Senior CMC Technical Advisor is responsible for overseeing and providing expert guidance on all aspects of Chemistry, Manufacturing, and Controls (CMC) activities throughout the product lifecycle. This role requires close collaboration with cross-functional teams to ensure compliance with regulatory standards, including FDA, EMA, and ICH guidelines. Key duties involve leading CMC strategy development, managing technical documentation for submissions, and resolving complex scientific challenges related to manufacturing processes and product quality. Additionally, the advisor plays a pivotal role in risk assessment, process optimization, and continuous improvement initiatives to enhance efficiency and scalability in production. Strong leadership, problem-solving skills, and an in-depth understanding of CMC principles are essential for success in this position.
Lead Good Manufacturing Practice (GMP) audits and deliver expert guidance to manufacturers on technology transfer processes, dossier development, and adherence to WHO Prequalification (PQ), PIC/S, and European Commission (EC) standards by conducting targeted training sessions and implementing best-practice methodologies.
Prepare technical documentation and tools to facilitate the localization of medical product manufacturing in low- and middle-income countries (Mics).
Assess potential CMC risks and develop mitigation strategies and contingency plans to maintain uninterrupted project progression.
Conduct compliance audits in accordance with WHO Prequalification and other international standards, providing guidance to manufacturers on corrective actions and compliance strategies.
Facilitate the establishment of collaborative public-private partnerships aimed at enhancing regional manufacturing ecosystems and broadening 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, ensuring their precision and adherence to established standards.
Monitor global and manufacturing regulatory trends, particularly in Africa, and disseminate key insights to internal stakeholders to support informed decision-making.
You will engage with global manufacturing forums on behalf of USP, actively participating in and influencing international policy dialogues.
Support program objectives by completing any additional CMC-related assignments delegated by leadership.
USP seeks a dynamic professional who thrives in a collaborative environment, bringing a strong commitment to equity, diversity, and inclusion to the forefront of their work. Candidates must possess a minimum of three years of relevant experience, a bachelor’s degree in a related field, and the ability to adapt to evolving priorities while maintaining high-quality outcomes. The ideal applicant will demonstrate exceptional problem-solving skills, a customer-focused mindset, and proficiency with data analysis and reporting tools. Responsibilities include engaging stakeholders, driving innovative initiatives, and ensuring compliance with organizational policies and regulatory standards.
The ideal candidate will demonstrate a clear understanding of our mission, uphold a commitment to excellence through inclusive and equitable behaviors and practices, and possess the ability to swiftly establish credibility with stakeholders. Additionally, they will meet the specified competencies and experience requirements.
Execute supplementary CMC responsibilities as directed by leadership to advance program goals.
A minimum of 10 years of practical experience in pharmaceutical manufacturing and process development is required.
Demonstrated proficiency in manufacturing processes, conducting comparability and feasibility studies, implementing stability programs, developing analytical methods, and compiling regulatory submissions is essential.
Proficient expertise in adhering to WHO Prequalification (PQ) criteria, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles along with Good Manufacturing Practice (GMP) standards applicable to pharmaceuticals, packaging, and associated processes is essential.
Proven expertise in managing and completing regulatory authority registration procedures.
Exceptional expertise in technical writing and verbal communication, demonstrated through the capacity to create meticulously crafted and accurate documentation.
Capable of and committed to traveling for work-related purposes up to 25% of the time.
Additional Desired Preferences
Preferred qualifications may be highlighted to demonstrate additional areas of expertise relevant to the role. Please note that items included in this section are neither mandatory nor will they impact a candidate’s consideration for the position.
Professional candidates will possess prior experience in at least one of the following critical health domains: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Expertise in the operation and optimization of essential manufacturing systems and processes, such as water systems, sterility assurance protocols, HVAC infrastructure, contamination control measures, analytical chemistry techniques, cleaning validation procedures, and formulation development methodologies, is required.
Experts in global market trends and supply chain complexities impacting the availability of quality-assured pharmaceuticals and medical products are sought.
Proficiency in navigating WHO Prequalification programs and other international regulatory frameworks is required.
Qualified candidates are preferred to be based in Kenya, while applicants from neighboring countries within the region are also encouraged to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
