We’re currently seeking a qualified candidate to fill the position with [Job Title], a key role responsible for [core responsibility 1], [core responsibility 2], and [core responsibility 3]. The ideal applicant must possess [required qualification 1], [required qualification 2], and [required qualification 3], along with [required skill 1] and [required skill 2]. In addition, experience with [specific tool/software/system] is a definite advantage. This role demands strong analytical abilities, meticulous attention to detail, and the capacity to [key competency 1]. Responsibilities include [detailed responsibility 1], [detailed responsibility 2], and [detailed responsibility 3], while collaborating closely with [team/department name] to achieve [specific objective or goal].
USP is looking for a Senior CMC Technical Advisor to strengthen its expertise and operational capacity in medical products manufacturing. The role involves delivering specialized technical guidance and supervision to manufacturers and regulatory bodies to ensure the availability of high-quality, essential medical products. The position requires collaboration with internal USP teams, medical product manufacturers, and regulatory authorities.
How will you drive meaningful contributions and foster positive change within USP’s dynamic environment?
In alignment with our commitment to upholding scientific integrity and elevating public health benchmarks, you will contribute substantially to expanding worldwide accessibility to superior pharmaceuticals via public standards and complementary initiatives. USP emphasizes scientific precision, adherence to regulatory requirements, and data-driven solutions to guarantee that health infrastructures globally can depend on robust, validated, and universally applicable quality benchmarks.
USP’s People and Culture division, in collaboration with the Equity Office, prioritizes leadership and workforce development initiatives to empower all employees with the competencies necessary for cultivating high-performing, inclusive teams. These efforts encompass training in equitable management practices as well as resources designed to foster engaged, collaborative, and results-oriented work environments.
Oversee a range of critical operational duties to ensure seamless workflow and adherence to established standards, while actively monitoring performance metrics and addressing any deviations promptly. Collaborate closely with cross-functional teams to align objectives, troubleshoot challenges, and implement process improvements that enhance productivity and efficiency. Maintain meticulous records, prepare detailed reports, and communicate key findings to stakeholders to support informed decision-making. Provide guidance and support to team members, fostering a collaborative environment that encourages professional growth and accountability. Ensure compliance with regulatory requirements and company policies, mitigating risks and upholding operational integrity at all times.
The Senior CMC Technical Advisor has the following responsibilities:
Lead GMP audits and guide manufacturers through technology transfer processes, dossier development, and adherence to WHO PQ, PIC/S, and EC standards by delivering specialized training and implementing best-practice methodologies.
Craft comprehensive technical documentation and implement specialized tools to facilitate the localization of medical product manufacturing processes in low- and middle-income countries.
Evaluate potential CMC risks, then develop mitigation strategies and contingency plans to safeguard project continuity.
Perform compliance audits in accordance with WHO Prequalification criteria and other internationally recognized standards, while advising manufacturers on corrective measures and compliance frameworks.
By fostering collaborative alliances between public and private sectors, we aim to enhance regional manufacturing ecosystems while expanding access to high-quality pharmaceutical products.
Work collaboratively with multidisciplinary teams to develop and execute manufacturing strategies that adhere to global best practices.
Thoroughly examine technical deliverables and donor reports to deliver timely, high-quality feedback, ensuring both accuracy and adherence to compliance standards.
Monitor global and regional manufacturing trends and regulatory frameworks, particularly within Africa, and provide strategic insights to internal stakeholders.
Represent USP in global manufacturing forums to play a key role in influencing international policy discussions.
Conduct supplementary CMC-related duties as directed by leadership to advance program goals.
USP seeks a highly motivated professional with a proven track record in their field to join our dynamic team. Candidates must meet all specified qualifications and demonstrate the ability to execute responsibilities with precision and efficiency. Ideal applicants will possess exceptional problem-solving skills, strong communication abilities, and a commitment to maintaining high standards of quality and integrity. Experience in relevant industries and a dedication to continuous improvement are essential for success in this role.
The ideal candidate will demonstrate a solid grasp of our mission, a dedication to excellence supported by inclusive and equitable behaviors and practices, and the capacity to rapidly establish trust with stakeholders. Additionally, the candidate must possess the following competencies and experience.
Execute any additional Chemistry, Manufacturing, and Controls (CMC) responsibilities designated by management to advance program goals.
A decade or more of practical involvement in pharmaceutical manufacturing and process development is essential.
Experienced in manufacturing operations, comparability and feasibility evaluations, stability protocols, analytical method development, and regulatory submission preparation.
Proficiency in WHO Prequalification (PQ) criteria, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards is essential.
A thorough grasp of Chemistry, Manufacturing, and Controls (CMC) principles along with Good Manufacturing Practice (GMP) standards applicable to pharmaceuticals, packaging, and associated processes is essential.
Proven track record in managing regulatory authority registration procedures.
Exceptional proficiency in both technical writing and verbal communication, demonstrated through the ability to craft meticulously detailed and high-caliber documentation.
Able to travel up to 25% of the time, with readiness to accommodate such arrangements.
Additional Desired Preferences
Preferred qualifications are welcomed to highlight any advanced skills or experience that may enhance performance in this role. It is important to note that items included in this section do not serve as mandatory requirements nor do they exclude candidates from consideration.
Proficiency in at least one of the following health domains is required: HIV/AIDS, malaria, or maternal, newborn, and child health (MNCH).
Proven hands-on expertise with essential manufacturing systems and processes, encompassing water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development.
Experts in navigating the complexities of international markets and supply chain operations that impact the availability of high-quality pharmaceuticals and medical products are strongly desired.
Proven expertise in navigating WHO Prequalification programs and other international regulatory pathways is essential.
While Kenya is the preferred location for this role, applicants from other countries within the region are also strongly encouraged to apply.
Qualifications
BA/BSc/HND
Experience Required
10 years
