Brief Job Overview
USP is currently recruiting a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The successful candidate will deliver expert technical guidance and supervision to manufacturers and regulatory bodies, ensuring the production of quality-assured essential medical products. This role involves active collaboration with both internal USP teams and external stakeholders, including medical product manufacturers and regulatory authorities.
How can you drive impactful results within our organization at USP?
You will contribute to USP’s mission of advancing scientific integrity and elevating public health benchmarks by facilitating worldwide access to superior medicines through public standards and complementary initiatives. USP upholds a steadfast commitment to scientific excellence, regulatory precision, and data-driven solutions to guarantee that health systems globally can depend on robust, validated, and universally applicable quality standards.
In collaboration with the Equity Office, USP’s People and Culture division enhances leadership and workforce capabilities through targeted development initiatives, enabling employees to build and sustain high-performing, inclusive teams. Offering specialized training in equitable management practices and practical tools, these programs foster engaged, collaborative, and outcome-focused work environments.
Oversee and manage daily operations and strategic initiatives to ensure alignment with organizational goals. Develop and implement policies, procedures, and best practices to enhance efficiency and productivity. Lead cross-functional teams, fostering collaboration and accountability to achieve project objectives. Monitor performance metrics and KPIs to identify trends, address gaps, and drive continuous improvement. Collaborate with senior leadership to shape long-term vision and execute business strategies. Ensure compliance with industry regulations, ethical standards, and internal policies.
The Senior CMC Technical Advisor is entrusted with a range of critical responsibilities, including overseeing and providing strategic guidance on CMC (Chemistry, Manufacturing, and Controls) development programs to ensure alignment with regulatory standards and business objectives. This role demands deep expertise in CMC matters, spanning drug substance and product development, manufacturing process optimization, and compliance with global regulatory requirements such as ICH, FDA, and EMA guidelines. Additionally, the advisor will collaborate closely with cross-functional teams—such as R&D, manufacturing, and quality assurance—to drive technical excellence, resolve complex CMC challenges, and support lifecycle management of products from early-stage development through commercialization. Strong leadership, problem-solving acumen, and the ability to articulate technical insights to diverse stakeholders are essential, along with a proven track record in CMC project leadership or advisory roles within the pharmaceutical or biotechnology industry.
Lead GMP audits while delivering technical guidance to manufacturers on technology transfer, dossier preparation, and adherence to WHO PQ, PIC/S, and EC standards through targeted training sessions and the implementation of best-practice methodologies.
Create comprehensive technical documentation and tools specifically designed to facilitate the localization of medical product manufacturing processes within low- and middle-income countries (Mics).
Assess CMC risks and develop mitigation strategies and contingency plans to safeguard project continuity.
Perform compliance audits in accordance with WHO Prequalification requirements and other relevant international benchmarks, offering support to manufacturers in developing and executing corrective measures and compliance frameworks.
You will cultivate and manage collaborative alliances between public and private sectors to enhance regional manufacturing capabilities and ensure broader accessibility to high-quality pharmaceutical products.
Partner with diverse teams spanning multiple functions to develop and execute manufacturing strategies that adhere to internationally recognized best practices.
Thoroughly evaluate technical deliverables and donor reports with precision and timeliness, delivering constructive feedback to uphold compliance and ensure accuracy.
Monitor global and regional manufacturing trends alongside regulatory requirements, particularly in Africa, and disseminate key insights to internal stakeholders for informed decision-making.
Serve as the organization’s ambassador in international manufacturing forums, playing a pivotal role in influencing global policy dialogues.
Execute any supplementary CMC-related assignments as directed by management to advance program goals.
USP is seeking candidates who meet the following qualifications and requirements. The ideal applicant will possess relevant experience and skills aligned with the role’s demands, demonstrating a strong understanding of the industry and its challenges. USP values individuals who exhibit analytical thinking, problem-solving abilities, and a commitment to excellence. Applicants should have a proven track record of success in their field, along with excellent written and verbal communication skills. Familiarity with industry-specific tools, software, or methodologies is highly desirable. USP also seeks professionals who thrive in collaborative environments, contribute creatively to projects, and uphold the organization’s core values of integrity, innovation, and accountability.
The ideal candidate will exhibit a firm grasp of our organizational mission, a steadfast dedication to excellence through inclusive and equitable behaviors and practices, and the capacity to swiftly establish trust and credibility among stakeholders, in addition to possessing the following competencies and experience.
Execute various CMC-related duties as directed by management to advance program goals.
A minimum of ten years of practical involvement in pharmaceutical manufacturing and process development is required.
Demonstrated proficiency in manufacturing processes, along with conducting comparability and feasibility studies, managing stability programs, advancing analytical development, and compiling regulatory submissions.
A comprehensive understanding of WHO Prequalification (PQ) requirements, PIC/S guidelines, WHO Technical Report Series publications, European Pharmacopoeia (EC) specifications, and UNICEF technical standards is essential.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) standards for pharmaceuticals, packaging, and associated disciplines is essential.
Possesses a proven track record in managing and completing regulatory authority registration procedures.
Proven expertise in crafting precise technical documentation and delivering clear, engaging oral presentations ensures consistent production of high-quality materials.
Open to traveling up to 25% of the time, both domestically and internationally, as required by business needs.
Additional Desired Preferences
Preferred qualifications are welcome to highlight any supplementary proficiency levels relevant to the role. Please note that entries in this section do not constitute mandatory criteria nor impact a candidate’s eligibility for consideration.
Professionals should possess demonstrated expertise in one or more of the following health domains: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Proven expertise in operating and optimizing essential manufacturing systems and processes such as water systems, sterility assurance protocols, HVAC infrastructure, contamination control measures, analytical chemistry applications, cleaning validation procedures, and formulation development methodologies.
Possesses a comprehensive knowledge of international market trends and supply chain complexities that impact the availability of high-quality, certified pharmaceuticals and medical supplies.
Proven expertise in navigating WHO Prequalification programs and other international regulatory pathways is required.
While a location preference is based in Kenya, we warmly invite qualified applicants from other regional countries to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
