We are seeking a highly motivated professional to join our team in the role of [Job Title]. This position requires a proven track record of [specific experience or skill] along with a minimum of [X years] of relevant experience. The ideal candidate will possess exceptional problem-solving abilities, strong analytical skills, and the capacity to work both independently and collaboratively within a fast-paced environment. Responsibilities include [detailed list of key duties], with an emphasis on delivering high-quality results while adhering to strict deadlines. Additional requirements encompass [specific qualifications, certifications, or technical proficiencies], along with excellent communication and organizational capabilities. Proficiency in [specific tools, software, or methodologies] is highly desirable, as is the ability to adapt to evolving priorities and challenges in the role.
USP is actively recruiting a Senior CMC Technical Advisor to enhance expertise and operational capacity in the manufacturing of medical products. The successful candidate will deliver expert technical guidance and regulatory oversight to manufacturers and governing bodies, ensuring the production of high-quality, essential medical products at scale. In this role, the advisor will collaborate closely with internal USP teams, medical product manufacturers, and regulatory authorities.
At USP, you’ll have the opportunity to drive meaningful contributions and foster tangible outcomes. How will you shape your role and generate lasting value within our organization?
As a key contributor, you will support our mission to elevate scientific rigor and public health standards by enhancing worldwide access to high-quality medicines through public standards and associated initiatives. USP upholds scientific integrity, regulatory excellence, and evidence-based decision-making to deliver robust, rigorously tested, and globally applicable quality standards that health systems can trust.
USP’s People and Culture division collaborates with the Equity Office to foster leadership and workforce growth, ensuring employees develop the competencies necessary to cultivate high-performing, inclusive teams. Initiatives encompass equitable management training and the implementation of tools designed to cultivate engaged, collaborative, and outcomes-focused work environments.
Oversee the execution of daily operational tasks to ensure seamless business functionality, maintaining focus on efficiency and accuracy. Collaborate with cross-functional teams to align objectives, streamline processes, and support organizational goals. Monitor performance metrics, identify areas for improvement, and implement corrective actions to enhance productivity and service quality. Prepare and present detailed reports summarizing key findings, trends, and recommendations for leadership review. Ensure compliance with industry regulations, company policies, and best practices to mitigate risks and uphold standards.
The Senior CMC Technical Advisor is tasked with overseeing critical aspects of CMC (Chemistry, Manufacturing, and Controls) development, ensuring compliance with regulatory standards and internal protocols. This role involves providing expert technical guidance throughout the product lifecycle, from early-stage development through commercialization. Responsibilities include leading CMC strategy planning, evaluating technical risks, and resolving complex issues that may arise during manufacturing processes or quality control assessments. Additionally, the advisor collaborates closely with cross-functional teams, including R&D, regulatory affairs, and operations, to facilitate seamless project execution and maintain alignment with business objectives. Strong leadership in CMC-related decision-making, coupled with a deep understanding of global regulatory requirements, is essential to this position.
Lead Good Manufacturing Practice (GMP) audits and deliver specialized technical guidance to manufacturers regarding technology transfer, dossier compilation, and adherence to WHO Prequalification (PQ), PIC/S, and European Commission (EC) regulatory standards. Conduct training sessions and implement best-practice methodologies to enhance compliance and operational efficiency across manufacturing processes.
Create technical documents and develop specialized tools specifically designed to facilitate the localization of medical product manufacturing within low- and middle-income countries (Mics).
Evaluate CMC risks, develop mitigation strategies, and establish contingency plans to safeguard uninterrupted project execution.
Conduct compliance audits in accordance with WHO Prequalification criteria and other relevant international benchmarks, while offering guidance to manufacturers on implementing corrective measures and developing robust compliance strategies.
By fostering collaborations between public and private sectors, enhance regional manufacturing ecosystems and expand the availability of high-quality pharmaceuticals.
Partner with diverse internal teams to develop and execute manufacturing initiatives in accordance with internationally recognized standards.
Ensure the meticulous review of technical deliverables and donor reports, delivering prompt, high-quality feedback to uphold accuracy and adherence to compliance standards.
Monitor global and regional manufacturing trends and regulatory frameworks, with particular emphasis on Africa, and provide strategic insights to internal stakeholders.
Represent USP in international manufacturing forums and play a key role in influencing global policy discussions.
Execute supplementary CMC-related assignments as directed by management to advance program goals.
USP is seeking a dynamic individual to join our team. Candidates should possess a strong background in [industry/field, if applicable], along with proven expertise in [specific skill or area]. Ideal applicants will demonstrate exceptional problem-solving abilities, adaptability to evolving challenges, and a commitment to delivering high-quality results. Responsibilities include [list key duties], while preferred qualifications encompass [mention any desired certifications, experience, or soft skills]. USP values collaboration, innovation, and integrity, making it an ideal environment for professionals eager to contribute to meaningful projects.
The ideal candidate will exhibit a deep comprehension of our mission, embodying a steadfast dedication to excellence through inclusive and equitable behaviors and practices. Additionally, they will demonstrate the capacity to swiftly establish trust and credibility with stakeholders, complemented by the following essential competencies and professional experience.
Execute supplementary CMC-related assignments as directed by management to uphold program goals.
A minimum of 10 years of practical experience in pharmaceutical manufacturing and process development is required.
Demonstrated proficiency in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and regulatory submission preparation.
Demonstrates comprehensive expertise in WHO Prequalification (PQ) criteria, PIC/S guidelines, the WHO Technical Report Series, EC specifications, and UNICEF technical standards.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles and Good Manufacturing Practice (GMP) standards applicable to medicinal products, packaging, and associated fields is required.
Proven track record in managing regulatory authority registration procedures is required.
Proven expertise in crafting clear, precise technical documentation alongside strong oral communication abilities, ensuring delivery of high-quality materials.
Able to travel as needed, up to 25% of the time, with flexibility to accommodate varying schedules.
Additional Desired Preferences
Preferred qualifications are welcomed to highlight any supplementary expertise that may enhance the performance of the role. It is important to note that items included in this section neither constitute mandatory requirements nor disqualify candidates from consideration.
Professional candidates should possess demonstrated experience in at least one of the following critical health domains: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Extensive hands-on experience with essential manufacturing systems and processes such as water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development is required.
Demonstrates a comprehensive grasp of international market forces and supply chain complexities that influence the availability of high-quality, certified pharmaceuticals and medical supplies.
Proficiency in navigating WHO Prequalification programs and other international regulatory frameworks is required.
Qualified candidates from across the region are welcome to apply, with preference given to applicants based in Kenya.
Qualifications
BA/BSc/HND
Experience Required
10 years
