Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high‑quality medicines worldwide.

USP is seeking a Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy to strengthen formulation development expertise and expand competencies in medical products manufacturing. The incumbent will play a critical role in advancing formulation technologies to enable local manufacturing of high‑quality medicines in low‑ and middle‑income countries. The incumbent will provide technical assistance and oversight to manufacturers to achieve increased supply of quality‑assured essential medical products and will interface with internal USP departments, manufacturers, and regulators.

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.

• Lead technical assistance in advanced formulation development for complex products, including complex generics and complementary supplements. Drive innovation in formulation strategies, technology transfer, and dossier preparation to ensure compliance with international quality standards.
• Serve as the primary subject matter expert on formulation science, guiding manufacturers through feasibility studies, stability programs, and optimization of formulations for commercialization.
• Support manufacturers to accelerate development, approval and commercialization of critical medicines.
• Support the USP CMC team to develop technical documents and tools on localizing manufacturing of medical products in LMIC.
• Identify CMC risks and support the development of mitigations and contingency plans.
• Conduct audits to assess compliance with international standards including from WHO Prequalification process and support manufacturers to develop strategies and tools to address deviations and non‑compliance identified.
• Actively contribute to the engagement of the private‑sector stakeholders to facilitate public‑private collaboration to support regional manufacturing of quality pharmaceuticals and medical products.
• Work closely with teams to support development and deployment of strategies.
• Review and provide timely inputs into key project deliverables including technical and donor reports.
• Keep abreast of the latest manufacturing trends and regulatory requirements, especially in Africa.
• Represent USP in international forums on manufacturing as directed by leadership.
• Other duties as assigned related to CMC workstream as directed by CMC technical director.

• BS, MS, or Ph.D. degree in pharmaceutical science, chemistry, engineering, or a science‑related field.
• Minimum of 10 years of experience in pharmaceutical manufacturing.
• Proven subject‑matter expertise in formulation science, including complex generic formulations, advanced drug delivery systems, comparability/feasibility studies, stability programs, and integration with analytical development and regulatory filings.
• Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines, packaging, and other relevant areas.
• Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development.
• Direct experience with regulatory authority registration processes…