Brief Job Overview
USP is in search of a Senior CMC Technical Advisor to enhance competencies and capabilities within medical products manufacturing. The selected candidate will deliver technical guidance and supervision to manufacturers and regulatory bodies to meet the goal of boosting the availability of quality-assured essential medical products. Additionally, the incumbent will collaborate with internal USP teams and external stakeholders, including medical product manufacturers and regulatory agencies.
How might you contribute to meaningful outcomes at USP?
As a key contributor to our mission of advancing scientific rigor and public health standards, you will be instrumental in expanding global access to high-quality medications through public standards and associated initiatives. USP upholds the highest principles of scientific integrity, regulatory excellence, and evidence-based decision-making to deliver robust, rigorously tested, and globally applicable quality standards that health systems worldwide can trust.
USP’s People and Culture division collaborates with the Equity Office to foster leadership and workforce development initiatives, empowering employees with the competencies necessary to cultivate high-performing, inclusive teams. The program encompasses training in equitable management methodologies and practical tools designed to cultivate engaged, collaborative, and results-oriented work environments.
The role entails overseeing daily operations, ensuring adherence to company policies and procedures, and maintaining high standards of efficiency and accuracy. Key responsibilities include managing team performance, fostering a collaborative work environment, and implementing strategies to enhance productivity. Additionally, the position requires coordinating with cross-functional departments to streamline processes, addressing operational challenges, and driving continuous improvement initiatives. Strong leadership, problem-solving skills, and a commitment to achieving organizational goals are essential for success in this position.
The Senior CMC Technical Advisor is tasked with overseeing critical aspects of CMC (Chemistry, Manufacturing, and Controls) development, ensuring compliance with regulatory standards and alignment with project objectives. This role demands a deep understanding of CMC principles, strong leadership in guiding cross-functional teams, and the ability to provide strategic technical direction for drug substance and product development. Responsibilities include reviewing and approving technical documentation, addressing CMC-related inquiries from regulatory authorities, and driving continuous improvement in manufacturing processes to enhance efficiency and product quality. Additionally, the position requires active participation in risk assessments, troubleshooting complex technical challenges, and mentoring junior team members to foster a culture of innovation and excellence.
Lead Good Manufacturing Practice (GMP) audits while offering specialized technical guidance to manufacturers on technology transfer initiatives, dossier compilation, and adherence to regulatory requirements such as WHO Prequalification (PQ), PIC/S, and European Commission (EC) standards. This role involves delivering targeted training sessions and implementing proven best-practice methodologies to ensure compliance and operational excellence.
Prepare technical documentation and create supporting tools to facilitate the localization of medical product manufacturing in low- and middle-income countries.
Conduct a thorough assessment of CMC risks, then develop and implement robust mitigation strategies alongside comprehensive contingency plans to safeguard project continuity and minimize potential disruptions.
Conduct compliance audits in alignment with WHO Prequalification criteria and other globally recognized standards, providing manufacturers with strategic guidance on corrective measures and compliance frameworks.
Collaborate with public and private stakeholders to enhance regional manufacturing capabilities and ensure broader availability of high-quality pharmaceutical products.
Partner with diverse teams across the organization to develop and execute manufacturing strategies that adhere to globally recognized best practices.
Ensure technical deliverables and donor reports are reviewed promptly and meticulously to maintain accuracy and compliance with all applicable standards.
Monitor global and regional manufacturing trends as well as evolving regulatory requirements, with particular emphasis on the African market, and provide valuable insights to internal stakeholders.
Represent USP in international manufacturing forums and engage in shaping global policy discussions.
Conduct various CMC-related assignments as directed by management to advance program goals.
USP is seeking qualified candidates to fill this pivotal role, where expertise, dedication, and a commitment to excellence are paramount. Ideal applicants should possess a proven track record in their field, complemented by strong analytical, problem-solving, and communication skills. Familiarity with relevant industry standards, technologies, or methodologies is essential, along with the ability to collaborate effectively within cross-functional teams. The successful hire will be responsible for driving key initiatives, ensuring adherence to best practices, and contributing to the organization’s strategic objectives through innovative solutions and meticulous execution.
The ideal candidate will exhibit a deep comprehension of our organizational mission, a steadfast dedication to excellence through inclusive and equitable behaviors and practices, and an aptitude for swiftly establishing trust with key stakeholders. Additionally, they will possess the competencies and experience outlined below.
Execute supplementary CMC-related duties as directed by management to advance program goals.
A minimum of ten years of practical experience in pharmaceutical manufacturing and process development is required.
Experienced professional with a strong background in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and regulatory submission preparation.
Possesses comprehensive expertise in WHO Prequalification (PQ) procedures, PIC/S guidelines, Technical Report Series from the World Health Organization (WHO), European Commission (EC) specifications, and technical standards mandated by the United Nations Children’s Fund (UNICEF).
Proficient knowledge of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) standards for pharmaceuticals, packaging, and associated fields is required.
Proficiency in managing regulatory authority registration procedures is essential.
Technical writing expertise and strong oral communication abilities are required to develop and deliver superior documentation.
Capable of and committed to traveling for up to 25% of working hours.
Additional Desired Preferences
Preferred qualifications are welcome to illustrate any extra skills or experience levels that could enhance performance in this role. It is important to note that items included in this section do not serve as mandatory prerequisites nor do they exclude candidates from consideration.
Proficiency in at least one of the following health domains is required: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Proven expertise in operating critical manufacturing systems and processes such as water systems, sterility assurance protocols, HVAC systems, contamination control measures, analytical chemistry techniques, cleaning validation procedures, and formulation development methodologies.
A comprehensive grasp of worldwide market trends and supply chain complexities impacting the availability of quality-assured pharmaceuticals and medical products is essential.
Experienced in actively participating in WHO Prequalification initiatives and navigating various international regulatory pathways.
Qualified individuals based in Kenya are preferred, though applicants from other regional countries are also welcomed to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
