Brief Job Overview
USP is looking to hire a Senior CMC Technical Advisor to enhance competencies and capabilities in the manufacturing of medical products. The primary responsibility of this role involves delivering technical support and oversight to manufacturers and regulatory bodies to ensure the increased availability of high-quality, essential medical products. This position requires collaboration with various internal USP departments as well as external stakeholders, including medical product manufacturers and regulatory authorities.
As part of the USP team, what unique contributions will you bring to drive meaningful results and foster innovation in our organization?
As a key contributor to our mission of elevating scientific integrity and public health benchmarks, your work will be instrumental in broadening global access to superior medicines via public standards and associated initiatives. USP is committed to upholding scientific accuracy, regulatory superiority, and data-driven choices to guarantee that health systems across the globe can depend on robust, validated, and universally applicable quality standards.
USP’s People and Culture division collaborates with the Equity Office to foster leadership and workforce growth, ensuring all employees acquire the competencies needed to build high-performing, inclusive teams. This initiative encompasses training in equitable management strategies and resources designed to cultivate engaged, collaborative, and results-oriented work environments.
Oversee and execute a diverse range of duties essential to the role, ensuring alignment with organizational objectives and operational standards. Develop, implement, and monitor strategies that enhance efficiency, productivity, and overall performance. Collaborate with cross-functional teams to identify opportunities for improvement and drive innovative solutions. Manage projects from inception to completion, adhering to deadlines, budgets, and quality benchmarks. Maintain accurate records, prepare detailed reports, and present findings to stakeholders to support informed decision-making. Address challenges proactively, troubleshoot issues, and implement corrective actions to mitigate risks. Foster a culture of accountability, professionalism, and continuous improvement within the team.
The Senior CMC Technical Advisor is responsible for providing expert guidance and support in all aspects of Chemistry, Manufacturing, and Controls (CMC) development and compliance. This role involves overseeing technical strategies to ensure alignment with regulatory standards and business objectives, as well as leading cross-functional teams to drive project timelines and resolve complex CMC challenges. Additionally, the advisor will review and approve key documentation, such as CMC sections of regulatory submissions, and mentor junior team members to enhance overall technical and regulatory expertise within the organization.
Lead GMP audits and deliver technical guidance to manufacturers on technology transfer, dossier preparation, and adherence to WHO PQ, PIC/S, and EC standards by conducting training sessions and implementing best-practice methodologies.
Prepare technical documentation and resources to facilitate the localization of medical product manufacturing processes in low- and middle-income countries (Mics).
Assess potential Chemistry, Manufacturing, and Controls (CMC) risks, then develop and implement mitigation strategies and contingency plans to safeguard uninterrupted project progression.
Conduct compliance audits in accordance with WHO Prequalification criteria and other internationally recognized standards, while also providing guidance to manufacturers on implementing corrective actions and developing robust compliance strategies.
Collaborate with public and private stakeholders to enhance regional manufacturing ecosystems and ensure broader access to high-quality pharmaceuticals.
Partner with diverse teams across the organization to develop and execute manufacturing strategies that adhere to worldwide industry standards.
Conduct thorough reviews of technical deliverables and donor reports to deliver prompt, meticulous feedback, ensuring their accuracy and compliance with established standards.
Analyze worldwide and continent-specific manufacturing trends and compliance mandates, particularly in Africa, and communicate key findings to relevant internal departments.
As a representative of USP, engage in international manufacturing forums to actively participate in and influence global policy discussions.
Execute additional CMC-related responsibilities as directed by leadership to advance program objectives.
USP is seeking a highly motivated and skilled professional to join our team. Ideal candidates will possess a strong academic background, relevant experience in their field, and a passion for innovation. The role requires excellent communication skills, the ability to collaborate effectively, and a commitment to delivering high-quality results. A proactive mindset, adaptability, and problem-solving abilities are essential. USP values diversity and encourages applicants from all backgrounds to apply, fostering an inclusive and dynamic work environment.
The ideal candidate will demonstrate a thorough grasp of our mission, embodying a steadfast dedication to excellence through inclusive and equitable approaches. They will possess the capability to swiftly establish trust and credibility among stakeholders, complemented by the following key competencies and professional experience.
Execute supplementary CMC-related assignments as directed by leadership to advance program goals.
A minimum of 10 years of practical experience in pharmaceutical manufacturing and process development is required.
Requires extensive experience in manufacturing processes, conducting comparability and feasibility studies, managing stability programs, advancing analytical development, and compiling regulatory submissions.
Proficient in WHO PQ guidelines, PIC/S regulations, WHO Technical Report Series, EC specifications, and UNICEF technical standards.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles alongside Good Manufacturing Practice (GMP) standards for pharmaceuticals, packaging, and associated domains is essential.
Proven track record in successfully managing regulatory authority registration processes.
Proficient in crafting comprehensive technical documentation and delivering clear, concise verbal communication to convey complex information effectively.
Demonstrates the capacity and flexibility to undertake travel obligations amounting to as much as 25% of the total work schedule.
Additional Desired Preferences
Preferred qualifications include the opportunity to highlight additional areas of expertise relevant to the position. It is important to note that items listed in this section do not serve as mandatory requirements nor do they impact a candidate’s eligibility for consideration.
Proficiency in one or more of the following health domains is required: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Experienced with essential manufacturing systems and processes such as water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development.
A comprehensive grasp of international market trends and supply chain complexities, specifically as they pertain to the availability of quality-assured pharmaceuticals and medical products, is essential.
Proficiency in navigating WHO Prequalification programs and other international regulatory frameworks is required.
A preference exists for candidates based in Kenya, but highly qualified individuals from neighboring regional countries are also welcome to submit their applications.
Qualifications
BA/BSc/HND
Experience Required
10 years
