Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy

USP•Rockville, MD

15d

About The Position

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. 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 minds—regardless of background—to 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. USP is seeking a Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy with strengthening formulation development expertise to expand competencies and capabilities in medical products manufacturing. The incumbent will play a critical role in advancing formulation technologies to enable local manufacturing of high-quality medicines in LMICs. The incumbent will be responsible for providing technical assistance and oversight to manufacturers 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 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.

Requirements

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

Nice To Haves

Experience in developing innovative formulations for challenging APIs (e.g., low solubility, high potency).
Expertise in scale-up and technology transfer of formulations from R&D to commercial manufacturing.
Experience in at least one of the following health areas: HIV/ AIDS, malaria, MNCH.
Experience with including water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, formulations, and other relevant areas.
Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products.
Direct experience with and understanding of WHO pre-qualification and/or other regulatory authority registration processes.

Responsibilities

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, the approval and commercialization of critical medicines.
Supports 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 regulation requirements especially in Africa.
Represents USP in international forums on manufacturing as directed by leadership.
Other duties as assigned related to CMC workstream as directed by CMC technical director.

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.

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