Scientific Affairs Manager
US Pharmacopeia
full-time
Posted on:
Location Type: Remote
Location: Florida • Maryland • United States
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Salary
💰 $112,700 - $146,900 per year
About the role
- Provide scientific guidance on the application and adoption of USP–NF monographs, general chapters, and compendial analytical methods
- Advice on the selection, qualification, and lifecycle management of USP Reference Standards
- Provide support and technical input to stakeholders on impurity profiling
- Build and sustain collaborative relationships with industry, regulators, academia, and scientific associations
- Monitor evolving scientific and regulatory trends across pharmaceutical R&D
- Collaborate cross functionally with science, marketing, regulatory, and strategic customer development teams
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
- 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
- Proficiency in English is required
Benefits
- company-paid time off
- comprehensive healthcare options
- retirement savings
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical methodsUSP–NF compendial standardsimpurity profilinganalytical testing proceduresregulatory knowledgepharmaceutical analytical sciencesimpurity control strategiesbiopharmaceutical developmentquality scienceregulatory science
Soft Skills
collaborative relationshipsstakeholder supportcross-functional collaborationscientific guidanceadvisory skills