Senior Scientist I, Analytical Development
Arrowhead Pharmaceuticals
August 29, 2026
Remote friendly (Madison, WI)
United States
Clinical Research and Development
Responsibilities:
- Work independently and collaboratively to deliver accurate, high-quality analytical results.
- Provide technical leadership, guidance, and mentorship to junior scientists.
- Serve as Analytical Project Coordinator or Lead, owning analytical activities (planning, prioritizing, coordinating testing).
- Design, develop, optimize, and validate analytical methods for all stages of drug substance/API and drug product development.
- Develop specifications and test methods for raw materials, in-process materials, intermediates, drug substances, and drug products.
- Lead analytical activities supporting process development, impurity characterization, GLP toxicology studies, and cGMP clinical trial materials.
- Analyze and interpret complex analytical data; troubleshoot and recommend follow-up activities.
- Prepare/review technical documentation (test methods, protocols/reports, SOPs, presentations).
- Communicate project status, analytical results, risks, and recommendations.
- Conduct work per applicable SOPs, cGMP requirements, regulatory guidelines, and industry standards.
- Contribute to continuous improvement; perform other duties as assigned.
Requirements:
- Ph.D. in Chemistry (2+ years) or M.S. (10+ years) or B.S. (12+ years).
- Analytical method development/optimization/qualification/validation experience for pharmaceutical drug substance and drug product.
- Experience developing analytical methods/specifications for raw materials, intermediates, drug substances, and drug products.
- Proficiency with HPLC, GC, FTIR, UV/Vis, LC/MS, Karl Fischer (KF), and related technologies.
- Strong instrumentation principles, test methodologies, and method validation knowledge.
- Strong CMC regulatory understanding (cGMP, ICH, FDA/CDER).
- Knowledge of synthetic organic chemistry principles; strong scientific judgment, troubleshooting, data interpretation, and organizational skills.
- Strong written/verbal communication and data quality/integrity commitment; effective independent and cross-functional teamwork.
Preferred:
- Mentorship/training experience.
- Analytical project lead/coordinator experience.
- Support across multiple stages of drug development; influence scientific direction and communicate recommendations across functions.
Benefits/Application instructions:
- Competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.
- Work independently and collaboratively to deliver accurate, high-quality analytical results.
- Provide technical leadership, guidance, and mentorship to junior scientists.
- Serve as Analytical Project Coordinator or Lead, owning analytical activities (planning, prioritizing, coordinating testing).
- Design, develop, optimize, and validate analytical methods for all stages of drug substance/API and drug product development.
- Develop specifications and test methods for raw materials, in-process materials, intermediates, drug substances, and drug products.
- Lead analytical activities supporting process development, impurity characterization, GLP toxicology studies, and cGMP clinical trial materials.
- Analyze and interpret complex analytical data; troubleshoot and recommend follow-up activities.
- Prepare/review technical documentation (test methods, protocols/reports, SOPs, presentations).
- Communicate project status, analytical results, risks, and recommendations.
- Conduct work per applicable SOPs, cGMP requirements, regulatory guidelines, and industry standards.
- Contribute to continuous improvement; perform other duties as assigned.
Requirements:
- Ph.D. in Chemistry (2+ years) or M.S. (10+ years) or B.S. (12+ years).
- Analytical method development/optimization/qualification/validation experience for pharmaceutical drug substance and drug product.
- Experience developing analytical methods/specifications for raw materials, intermediates, drug substances, and drug products.
- Proficiency with HPLC, GC, FTIR, UV/Vis, LC/MS, Karl Fischer (KF), and related technologies.
- Strong instrumentation principles, test methodologies, and method validation knowledge.
- Strong CMC regulatory understanding (cGMP, ICH, FDA/CDER).
- Knowledge of synthetic organic chemistry principles; strong scientific judgment, troubleshooting, data interpretation, and organizational skills.
- Strong written/verbal communication and data quality/integrity commitment; effective independent and cross-functional teamwork.
Preferred:
- Mentorship/training experience.
- Analytical project lead/coordinator experience.
- Support across multiple stages of drug development; influence scientific direction and communicate recommendations across functions.
Benefits/Application instructions:
- Competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.