Brief Job Overview
USP is looking for a Senior CMC Technical Advisor to strengthen its expertise and operational capacities in the manufacturing of medical products. The successful candidate will deliver technical guidance and supervision to manufacturers and regulatory bodies to ensure the availability of high-quality, essential medical products. This role involves collaboration with internal USP teams, medical product manufacturers, and regulatory authorities.
How will you contribute to meaningful outcomes while supporting USP’s mission and objectives?
You will contribute significantly to our mission of promoting scientific rigor and elevating public health standards by facilitating broader global access to premium medicines through public standards and associated initiatives. USP upholds a commitment to scientific integrity, regulatory rigor, and evidence-driven decision-making to guarantee that health systems internationally can depend on robust, validated, and globally applicable quality standards.
USP’s People and Culture division, in collaboration with the Equity Office, fosters leadership and workforce development initiatives designed to empower employees with the competencies needed to cultivate high-performing, inclusive teams. These efforts encompass specialized training in equitable management practices and provide tools to cultivate engaged, collaborative, and results-oriented workplace environments.
Develops and implements strategic plans to ensure efficient operation of the department, aligning with organizational objectives. Oversees project execution, monitors progress, and ensures adherence to deadlines and budgets. Collaborates with cross-functional teams to identify opportunities for improvement and drive operational excellence. Manages team performance, fostering a culture of accountability and continuous development. Conducts regular performance evaluations and provides constructive feedback to enhance productivity. Maintains open communication channels with stakeholders to ensure alignment and transparency. Ensures compliance with company policies, industry regulations, and best practices.
The Senior CMC Technical Advisor is tasked with overseeing critical aspects of CMC (Chemistry, Manufacturing, and Controls) development, ensuring alignment with regulatory standards and organizational objectives. Responsibilities include providing strategic guidance on CMC-related matters, evaluating technical proposals, and advising on process optimization and compliance strategies. Additionally, this role involves collaborating with cross-functional teams to resolve complex technical challenges, reviewing and approving CMC documentation, and supporting regulatory submissions to ensure adherence to global health authority requirements. The position demands a deep understanding of CMC principles, strong problem-solving skills, and the ability to mentor junior team members while maintaining high standards of quality and efficiency.
Conduct GMP audits and deliver specialized technical support to manufacturers regarding technology transfer, dossier preparation, and adherence to WHO PQ, PIC/S, and EC regulatory standards by implementing training initiatives and deploying best-practice methodologies.
Prepare technical documentation and create supporting tools to facilitate the localization of medical product manufacturing in low- and middle-income countries (Mics).
Assess CMC risks and develop mitigation strategies and contingency plans to safeguard project continuity.
Conduct compliance audits in accordance with WHO Prequalification requirements and other globally recognized standards, providing manufacturers with expert guidance on corrective action implementation and robust compliance strategies.
Leverage collaborative alliances between public and private sectors to enhance local manufacturing capacities and ensure broader availability of high-quality pharmaceutical products.
Partner with diverse teams across departments to develop and execute manufacturing strategies in accordance with globally recognized best practices.
Evaluate technical deliverables and donor reports promptly, ensuring their precision and adherence to required standards while maintaining high-quality contributions.
Track and evaluate global and regional manufacturing trends and regulatory frameworks, particularly within Africa, and disseminate key findings to relevant internal stakeholders.
You will represent USP in international manufacturing forums and play a key role in shaping global policy discussions.
Support program goals by executing supplementary CMC-related responsibilities as directed by leadership.
USP is seeking qualified candidates who possess exceptional analytical abilities, a strong commitment to detail, and the capacity to thrive in a dynamic, high-performance environment. Ideal applicants will demonstrate a proven track record of delivering measurable results, collaborating effectively within cross-functional teams, and demonstrating adaptability in a fast-paced workplace. Candidates must meet all specified technical requirements and possess the interpersonal skills necessary to communicate complex ideas clearly and persuasively to diverse stakeholders.
The ideal candidate will demonstrate a clear grasp of our mission, a dedication to excellence through inclusive and equitable approaches, and the capacity to swiftly establish trust and credibility with stakeholders. Additionally, they should possess the following competencies and experience.
Execute various CMC-related assignments as directed by management to further program goals and objectives.
A minimum of a decade of practical expertise in pharmaceutical manufacturing and process development is required.
Requires demonstrated proficiency in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and regulatory submission preparation.
Proficient in WHO Prequalification (PQ) procedures, PIC/S guidelines, WHO Technical Reports, EC specifications, and UNICEF technical standards, ensuring compliance with international regulatory frameworks.
An in-depth knowledge of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) standards, including their application to pharmaceuticals, packaging, and associated domains, is essential.
Experienced in managing regulatory authority registration procedures with a proven track record.
Exceptional proficiency in technical writing and oral communication is required, enabling the production of high-quality documentation.
Able to travel up to 25% of the time as required.
Additional Desired Preferences
Preferred qualifications are opportunities to highlight additional areas of expertise relevant to the role. Please note that items in this section are neither mandatory nor will they exclude candidates from consideration.
Applicants should possess prior expertise in at least one of the following health sectors: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Experienced professionals should have hands-on familiarity with essential manufacturing systems and processes such as water systems, sterility assurance, HVAC systems, contamination control measures, analytical chemistry applications, cleaning validation protocols, and formulation development methodologies.
Demonstrates a comprehensive grasp of international market forces and supply chain complexities that directly impact the availability and integrity of high-quality pharmaceuticals and medical products.
Experienced in implementing WHO Prequalification programs and navigating other international regulatory pathways.
While a preferred location is Kenya, applications from qualified candidates across other regional countries are also welcome.
Qualifications
BA/BSc/HND
Experience Required
10 years
