CMC Senior Technical Advisor at US Pharmacopeial Convention (USP)

Brief Job Overview

• This is a non‑supervisory, individual contributor position designed to operate at a strategic level in order to expand competencies and capabilities in manufacturing medical products. The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators, engaging with relevant stakeholders and supporting efforts to increase the supply of quality‑assured essential medical products. In carrying out these responsibilities, the incumbent will work closely with internal USP departments as well as external manufacturers and regulatory authorities.

How will YOU create impact here 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.

Responsibilities

The CMC Senior Technical Advisor has the following responsibilities:

• Lead technical assistance in advanced formulation development for complex products, including complex generics, driving innovation in formulation strategies, technology transfer, and dossier development in alignment with international quality standards.
• Serve as subject matter expert in formulation science, guiding manufacturers through feasibility studies, stability programs, and formulation optimization to support successful commercialization.
• Support manufacturers in accelerating the development, regulatory approval, and commercialization of critical medicines.
• Creating technical documents and practical tools that advance localized manufacturing of medical products in LMICs.
• Lead GMP audits and provide technical assistance on technology transfer, dossier development, and WHO Prequalification compliance, including delivering training and best‑practice tools.
• Develop technical documents and tools that strengthen efforts to localize manufacturing of medical products in LMICs.
• Identify CMC‑related risks and design mitigation strategies and contingency plans to ensure continuity and success of project objectives.
• Conduct compliance audits in alignment with WHO PQ and other international regulatory standards; guide manufacturers in implementing corrective actions and strengthening compliance systems.
• Work closely with other program technical teams to ensure the deployment of MedSuRe Africa holistic implementation strategies.
• Facilitate public–private partnerships to strengthen regional manufacturing ecosystems and expand access to quality‑assured pharmaceuticals.
• Collaborate with cross‑functional internal and external stakeholders to design and implement manufacturing strategies aligned with global best practices.
• Review and provide timely, high‑quality technical input for deliverables and donor reports to ensure accuracy, completeness, and compliance.
• Monitor global and regional manufacturing trends and evolving regulatory requirements—particularly in Africa—and disseminate insights to inform internal teams.
• Represent USP in international manufacturing forums and contribute to shaping global discussions on pharmaceutical manufacturing policy.
• Perform additional CMC‑related responsibilities as assigned by program leadership to advance organizational and project goals.

Who is USP Looking For?

The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience

• 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 including with the USFDA.
• BS, MS, or Ph.D. degree in, pharmaceutical science, chemistry, engineering, or science related field of study required.
• Strong written (especially technical writing) and oral communication skills.
• Willingness to travel up to 25% of the time.