We are seeking a highly motivated individual to fill the role of [Job Title], a critical position within our organization. The successful candidate will be responsible for [specific responsibility 1], [specific responsibility 2], and [specific responsibility 3]. Additionally, this role requires a minimum of [X] years of relevant experience in [field/industry], along with proficiency in [specific skill or tool]. Strong analytical, communication, and problem-solving skills are essential, as is the ability to work both independently and collaboratively in a fast-paced environment. The ideal candidate will demonstrate a track record of [specific achievement or quality] and possess a deep understanding of [relevant subject or process]. This position offers opportunities for professional growth and development within a dynamic and innovative team.
USP is actively 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 authorities, ensuring the fulfillment of objectives aimed at boosting the availability of quality-assured essential medical products. The role requires collaboration with internal USP teams, medical product manufacturers, and regulatory bodies.
How will you contribute to making a meaningful difference at USP?
As a key contributor to our mission of enhancing scientific rigor and public health standards, you will be instrumental in expanding global access to superior medicines via public standards and associated initiatives. USP upholds principles of scientific integrity, regulatory excellence, and evidence-based decision-making to guarantee that 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 necessary skills to cultivate high-performing, inclusive teams. This initiative encompasses training in equitable management practices and the implementation of tools designed to encourage engagement, collaboration, and results-oriented work environments.
Oversee the execution of daily operations to ensure optimal performance and efficiency across all assigned tasks. Collaborate with cross-functional teams to align objectives and deliver high-quality results in accordance with organizational standards. Monitor progress through established metrics, identifying areas for improvement and implementing corrective actions as needed. Maintain clear communication with stakeholders to provide updates, address concerns, and foster a collaborative work environment. Conduct regular assessments of team productivity and resource allocation to enhance workflow and achieve strategic goals. Ensure compliance with company policies, industry regulations, and best practices to uphold operational integrity and accountability.
The Senior CMC Technical Advisor is tasked with overseeing and guiding critical aspects of Chemistry, Manufacturing, and Controls (CMC) processes, ensuring compliance with regulatory standards and operational excellence. This role involves providing expert technical leadership to cross-functional teams, developing robust manufacturing strategies, and optimizing production methodologies to enhance efficiency and scalability. Additionally, the Senior CMC Technical Advisor plays a key role in addressing complex technical challenges, conducting thorough risk assessments, and implementing corrective actions to mitigate potential issues. Strong collaboration with quality assurance, research and development, and production teams is essential to drive continuous improvement and maintain high standards of product quality and regulatory compliance.
Lead GMP audits while delivering expert technical guidance to manufacturers on technology transfer initiatives, dossier compilation, and adherence to WHO PQ, PIC/S, and EC regulatory standards. Facilitate training sessions and implement best-practice methodologies to ensure full compliance and operational excellence.
Prepare technical documentation and tools specifically designed to facilitate the localization of medical product manufacturing in low- and middle-income countries (Mics).
Identify potential risks in Chemistry, Manufacturing, and Controls (CMC) and develop mitigation strategies along with contingency plans to maintain uninterrupted project progression.
Perform compliance audits in accordance with WHO Prequalification criteria and other globally recognized standards while providing manufacturers with guidance on corrective measures and effective compliance strategies.
We work to foster collaborative public-private partnerships that enhance regional manufacturing ecosystems and increase accessibility to high-quality pharmaceuticals.
Partner with diverse teams across various functions to develop and execute manufacturing strategies in accordance with globally recognized best practices.
Evaluate technical deliverables and donor reports promptly, ensuring they meet rigorous standards for accuracy and compliance.
Monitor global and regional manufacturing trends, particularly within Africa, while staying current on evolving regulatory requirements. Disseminate these insights to internal teams to support informed decision-making and strategic alignment.
Represent USP in international manufacturing forums, playing an active role in influencing global policy discussions and sharing expertise to drive consensus on key issues.
Execute supplementary CMC-related assignments as directed by management to facilitate the achievement of program goals.
USP is seeking a highly motivated professional to join our team, bringing a blend of relevant experience and a passion for excellence. We require candidates with a strong background in [specific field or industry, if mentioned in original], coupled with exceptional problem-solving abilities and a commitment to delivering high-quality results. The ideal candidate will possess proven analytical skills, effective communication capabilities, and the ability to collaborate seamlessly within a dynamic team environment. Responsibilities include [list key responsibilities, if provided in original], ensuring strict adherence to industry standards and organizational protocols.
The ideal candidate will exhibit a deep comprehension of our mission, demonstrate unwavering dedication to excellence through inclusive and equitable behaviors and practices, and possess the capacity to swiftly establish trust and credibility with stakeholders. Additionally, they must meet the specified competencies and professional experience outlined below.
Execute supplementary CMC-related responsibilities as directed by management to advance program goals.
A decade or more of practical involvement in pharmaceutical manufacturing and process development is required.
A demonstrated proficiency in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and the preparation of regulatory submissions is required.
Proficiency in WHO Prequalification (PQ) standards, PIC/S guidelines, WHO Technical Report Series publications, European Pharmacopoeia (EP) specifications, and UNICEF technical requirements is essential.
A thorough knowledge of Chemistry, Manufacturing, and Controls (CMC) principles alongside Good Manufacturing Practice (GMP) standards applicable to pharmaceuticals, packaging, and associated disciplines is required.
Proven track record in managing regulatory authority registration processes adeptly.
Exceptional proficiency in both technical writing and oral communication, demonstrated through the consistent creation of high-quality documentation.
Demonstrated willingness and capacity to travel extensively, amounting to up to 25% of overall work time.
Additional Desired Preferences
Desired preferences include the opportunity to highlight any supplementary areas of expertise relevant to fulfilling the role effectively. It is important to note that any criteria outlined in this section do not serve as mandatory requirements nor do they exclude candidates from consideration.
Proficiency in one or more of the following health domains is required: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Experienced professionals should possess hands-on knowledge of essential manufacturing systems and processes, such as water systems, sterility assurance, HVAC systems, contamination control, analytical chemistry techniques, cleaning validation protocols, and formulation development methodologies.
Possesses comprehensive knowledge of international market forces and supply chain complexities that influence the availability of high-quality, assured pharmaceutical and medical products.
Experienced in navigating and implementing WHO Prequalification programs, along with familiarity with other international regulatory pathways.
Qualified applicants based in Kenya are preferred, though we strongly encourage candidates from other countries within the region to submit their applications as well.
Qualifications
BA/BSc/HND
Experience Required
10 years
