Brief Job Overview
US Pharmacopeia (USP) is seeking a Senior Chemistry, Manufacturing, and Controls (CMC) Technical Advisor to expand competencies and capabilities in medical products manufacturing. The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products. The incumbent will interface with internal USP departments as well as manufacturers of medical products and regulators.
Impact at USP
As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
Key Responsibilities
- Lead GMP audits and provide technical assistance to manufacturers on technology transfer, dossier development, and compliance with WHO PQ, PIC/S, and EC standards through training and deployment of best-practice tools.
- Develop technical documents and tools to support localization of medical product manufacturing in LMICs.
- Identify CMC risks and design mitigation strategies and contingency plans to ensure project continuity.
- Conduct compliance audits aligned with WHO Prequalification and other international standards; guide manufacturers in implementing corrective actions and compliance strategies.
- Facilitate public-private partnerships to strengthen regional manufacturing ecosystems and improve access to quality pharmaceuticals.
- Collaborate with cross-functional teams to design and implement manufacturing strategies that align with global best practices.
- Review and provide timely, high-quality input on technical deliverables and donor reports to ensure accuracy and compliance.
- Monitor global and regional manufacturing trends and regulatory requirements, with a focus on Africa, and share insights with internal teams.
- Represent USP in international manufacturing forums and contribute to shaping global policy discussions.
- Perform additional CMC-related tasks as assigned by leadership to support program objectives.
Requirements and Qualifications
- Education: Minimum of a BA/BSc/HND degree in a relevant scientific or engineering discipline.
- Experience: Minimum of 10 years of hands-on experience in pharmaceutical manufacturing and process development.
- Technical Expertise: Proven expertise in manufacturing processes, comparability and feasibility studies, stability programs, analytical development, and preparation of regulatory submissions.
- Standard Compliance: In-depth knowledge of WHO PQ, PIC/S guidelines, WHO Technical Report Series, EC specifications, and UNICEF technical standards.
- CMC & GMP Knowledge: Comprehensive understanding of CMC principles and GMP requirements for medicines, packaging, and related areas.
- Regulatory Navigation: Demonstrated experience navigating regulatory authority registration processes.
- Communication: Exceptional technical writing and oral communication skills, with ability to produce high-quality documentation.
- Travel: Willingness and ability to travel up to 25% of the time.
Additional Desired Preferences
- Experience in at least one of the following health areas: HIV/ AIDS, malaria, MNCH.
- Practical experience with critical manufacturing systems and processes, including water systems, sterility assurance, HVAC, contamination control, analytical chemistry, cleaning validation, and formulation development.
- Strong understanding of global market dynamics and supply chain challenges affecting access to quality-assured pharmaceuticals and medical products.
- Hands-on experience with WHO Prequalification programs and other international regulatory pathways.
- Preferred location in Kenya, though qualified candidates from other countries in the region are encouraged to apply.
