We are seeking a highly motivated and skilled individual to join our team in the position of [Job Title]. The ideal candidate will possess a strong academic background in [relevant field] and at least [X] years of hands-on experience in [specific area]. Proficiency in [key software/tools] and excellent communication skills are essential for success in this role. Key responsibilities include [specific duty 1], [specific duty 2], and [specific duty 3], with a focus on delivering high-quality results within strict deadlines. The candidate must demonstrate the ability to work both independently and collaboratively in a fast-paced environment while maintaining a strong attention to detail. Additional requirements include [specific requirement 1], [specific requirement 2], and the capacity to adapt to evolving industry trends and technologies.
USP is looking for 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 goals of boosting the supply of high-quality, essential medical products are met. The role involves collaboration with various internal USP teams, as well as with external stakeholders, including medical product manufacturers and regulatory authorities.
How might you contribute meaningfully to USP in this role?
You will contribute significantly to our objective of enhancing scientific rigor and public health standards by facilitating worldwide access to premium medications 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, ensuring all employees acquire the competencies necessary to cultivate high-performing, inclusive teams. This encompasses specialized training in equitable management strategies and practical tools designed to enhance engagement, collaboration, and productivity within the workplace.
Oversee and execute day-to-day operations to ensure smooth functionality of assigned tasks. Drive project completion by coordinating resources, timelines, and team efforts while adhering to established policies and procedures. Monitor progress, identify potential risks, and implement corrective measures to maintain efficiency and productivity. Develop and maintain strong working relationships with colleagues, stakeholders, and external partners to foster collaboration and alignment. Ensure compliance with industry regulations, quality standards, and safety protocols to mitigate risks and uphold organizational integrity.
The Senior CMC Technical Advisor is responsible for overseeing critical aspects of development, ensuring compliance with regulatory standards, and providing strategic guidance to stakeholders. This role involves leading technical teams to address complex Chemistry, Manufacturing, and Controls (CMC) challenges, optimizing processes for efficiency and scalability, and supporting regulatory submissions for product approval. Additionally, the position requires collaborating with cross-functional teams to resolve technical issues, maintaining up-to-date knowledge of industry trends, and mentoring junior staff to enhance their expertise in CMC principles.
Lead GMP audits while offering expert 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 industry-leading best practices.
Draft technical documentation and author supporting tools specifically designed to facilitate the localization of medical product manufacturing processes within low- and middle-income countries.
Assess potential CMC-related risks and develop mitigation strategies and contingency plans to safeguard project continuity.
Conduct compliance audits in accordance with WHO Prequalification criteria and other relevant international standards, providing manufacturers with strategic guidance on implementing corrective actions and achieving compliance.
We collaborate with public and private sector stakeholders to enhance regional manufacturing ecosystems and ensure broader access to high-quality pharmaceuticals through strategic partnerships.
Partner with diverse teams across the organization to develop and execute manufacturing strategies that meet globally recognized standards and industry best practices.
Evaluate technical deliverables and donor reports promptly, delivering meticulous feedback to verify accuracy and adherence to requirements.
Analyze worldwide and continent-specific manufacturing developments, particularly in Africa, while staying current with regulatory mandates, then disseminate key findings to relevant internal stakeholders.
Represent USP in international manufacturing forums, actively engaging in and influencing global policy discussions to uphold and advance our standards.
Execute additional CMC-related responsibilities as directed by management to advance program goals.
USP is in search of individuals who demonstrate a strong commitment to excellence and innovation in their professional pursuits. The ideal candidates will possess a proven track record of delivering high-quality results, coupled with the ability to adapt to dynamic environments. Proficiency in relevant technical skills, along with effective communication and collaboration abilities, is essential. Additionally, candidates should exhibit a dedication to continuous learning and professional growth, aligning with USP’s core values and mission.
The ideal candidate will embody our mission through a steadfast commitment to excellence, demonstrated through inclusive and equitable behaviors and practices. They will possess the ability to rapidly establish trust and credibility with stakeholders while bringing the following competencies and experience to the role.
Execute supplementary CMC-related duties as directed by management to advance programmatic goals.
A decade or more of practical engagement in pharmaceutical manufacturing and process development is required.
Accomplished professionals must demonstrate a strong command of manufacturing processes, alongside conducting comparability and feasibility studies, managing stability programs, advancing analytical development, and compiling regulatory submissions.
Proficient expertise in WHO Prequalification (PQ), PIC/S guidelines, the WHO Technical Report Series, EC specifications, and UNICEF technical standards is required.
Profound knowledge of Chemistry, Manufacturing, and Controls (CMC) principles alongside Good Manufacturing Practice (GMP) mandates for pharmaceuticals, packaging, and associated domains is essential.
Proven track record in managing regulatory authority registration procedures.
Exceptional proficiency in both technical writing and oral communication, demonstrated through the creation of meticulously crafted documentation.
Capable of and open to traveling up to 25% of the time.
Additional Desired Preferences
Preferred attributes include the opportunity to present additional areas of expertise relevant to the position. It is important to note that items outlined in this section are neither mandatory requirements nor grounds for disqualification from consideration.
Professionals with expertise in at least one of the following health domains are encouraged to apply: HIV/AIDS, malaria, or Maternal, Newborn, and Child Health (MNCH).
Proven 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.
Proficient in analyzing global market trends and supply chain complexities that impact the availability of high-quality, assured pharmaceuticals and medical products.
Applicants should possess practical expertise in WHO Prequalification programs as well as other internationally recognized regulatory pathways.
Qualified candidates based in Kenya are preferred, yet applicants from neighboring countries across the region are also strongly encouraged to apply.
Qualifications
BA/BSc/HND
Experience Required
10 years
