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Scientific Affairs Manager
US PharmacopeiaScientific Affairs Manager at USP enhancing public health through scientific standards and stakeholder collaboration. Required advanced degree and extensive experience in life sciences and regulatory knowledge.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
- 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
- Proficiency in English is required
- Korean and other language knowledge is added advantage
Benefits
Comp & perks- Health insurance
- Paid time off
- Retirement savings
ATS Keywords
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Hard Skills & Tools
analytical methodsUSP–NF standardsimpurity profilinganalytical method developmentvalidationverificationsystem suitabilityquality controlregulatory sciencebiopharmaceutical development
Soft Skills
collaborative relationshipsscientific presentationscommunicationtroubleshootingcustomer engagementregulatory engagementcross-functional collaborationstakeholder supportworkshop deliveryscientific guidance
Certifications
Master’s degreePh.D.