CMC Senior Technical Advisor

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds 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 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a nonâsupervisory 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 qualityâassured essential medical 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 USPs 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.

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 bestâpractice tools.
• Develop technical documents and tools that strengthen efforts to localize manufacturing of medical products in LMICs.
• Identify CMCârelated 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 publicprivate partnerships to strengthen regional manufacturing ecosystems and expand access to qualityâassured pharmaceuticals.
• Collaborate with crossâfunctional internal and external stakeholders to design and implement manufacturing strategies aligned with global best practices.
• Review and provide timely highâquality technical input for deliverables and donor reports to ensure accuracy completeness and compliance.
• Monitor global and regional manufacturing trends and evolving regulatory requirementsparticularly in Africaand disseminate insights to inform internal teams.
• Represent USP in international manufacturing forums and contribute to shaping global discussions on pharmaceutical manufacturing policy.
• Perform additional CMCârelated 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.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Senior IC