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About the Role
This role contributes to expanding access to high-quality medicines through public standards and related programs by communicating and amplifying USP’s science, strengthening scientific visibility and external engagement with customers, regulatory authorities, and key stakeholders. The position supports the understanding, adoption, and appropriate applications of USP compendial standards including analytical methods, reference standards, and impurity controls across pharmaceutical and selected biopharmaceutical products. This role translates complex scientific and technical content into clear, impactful engagement strategies and insights, while capturing regional scientific and regulatory intelligence to inform organizational priorities and planning.
Responsibilities
- Provide scientific guidance on the application and adoption of USP–NF monographs, general chapters, and compendial analytical methods, including validation, verification, and system suitability.
- Advice on the selection, qualification, and lifecycle management of USP Reference Standards in accordance with compendial expectations.
- Provide support and technical input to stakeholders on impurity profiling, control strategies, analytical method development, transfer, troubleshooting, and compendial compliance in alignment with USP standards and ICH guidelines.
- Build and sustain collaborative relationships with industry, regulators, academia, and scientific associations.
- Deliver scientific presentations, workshops, and customer & regulatory engagements to support awareness and adoption of USP standards.
- Monitor evolving scientific and regulatory trends across pharmaceutical R&D, quality control, and manufacturing.
- Gather and communicate regional scientific and regulatory feedback to internal USP scientific and cross-functional teams.
- Collaborate cross functionally with science, marketing, regulatory, and strategic customer development (SCD) teams to provide scientific input.
Requirements
- Master’s degree with 6-8 years, or Ph.D. with 4–6 years of experience in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Chemistry, Biotechnology, or a related discipline, including demonstrated experience with USP–NF tests and standards, compendial methods, and regulatory requirements.
- Minimum of 2 years of experience working in pharmaceutical or biopharmaceutical development, quality, regulatory science, or analytical sciences.
- Knowledge of various analytical testing procedures and methodologies, and regulatory knowledge (FDA, ICH, etc.) for approval of bio-/pharmaceutical products.
- Demonstrated expertise in pharmaceutical analytical sciences, with strong working knowledge of USP–NF compendial standards, analytical methods, and reference standards.
- Strong understanding of impurity control strategies, including organic, inorganic, elemental impurities, residual solvents, extractables and leachable.
- Exposure to USP compendial testing, analytical methods, or reference materials is highly desirable.
- Biopharmaceutical knowledge is retained but positioned as supporting USP’s portfolio.
- Good understanding of impurity testing, extractables and leachable, sterility testing would be an added advantage.
- Proficiency in English is required.
- Strong presentation and communication skills (written and oral).
- Knowledge of the bio-/pharmaceutical industry and the associated regulatory framework is essential.
- Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.
- Experience working and engaging external customers and stakeholders in scientific fields.
- Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
- Well-developed organizational, interpersonal communications, writing, and strong listening skills.
- Self-motivated with ability to collaborate cross functionally and experience working in global environment.
- Experience working with government and regulatory authorities would be an added advantage.
Skills
- USP–NF tests and standards
- Compendial methods
- Regulatory requirements
- Pharmaceutical or biopharmaceutical development
- Quality
- Regulatory science
- Analytical sciences
- Analytical testing procedures and methodologies
- FDA
- ICH
- Pharmaceutical analytical sciences
- USP–NF compendial standards
- Analytical methods
- Reference standards
- Impurity control strategies
- Organic impurities
- Inorganic impurities
- Elemental impurities
- Residual solvents
- Extractables and leachable
- USP compendial testing
- USP reference materials
- Biopharmaceutical knowledge
- Impurity testing
- Sterility testing
- English
- Korean
- Presentation skills
- Communication skills
- Bio-/pharmaceutical industry
- Regulatory framework
- Organizational skills
- Interpersonal communications
- Writing skills
- Listening skills
Location
- Tokyo
- Osaka
Work Type
- Onsite
- Hybrid
Experience Level
- 6-8 years
- 4-6 years
- Minimum of 2 years
Education Level
- Master’s degree
- Ph.D.
Benefits
- Company-paid time off
- Comprehensive healthcare options
- Retirement savings
About the Company
- 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.
Equal Opportunity
- 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.