Principal Bioanalytical Scientist, GLP PK Methods

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Scientist to join the GLP Bioanalytical group within the Clinical Pharmacology and DMPK department in Madison, WI.

You will lead bioanalytical method development, transfer, qualification, validation, and sample analysis for pharmacokinetic studies across development stages. The successful candidate will have hands-on LC-MS/MS, LC-FL, hybrid assays, and immunoassays experience, with a strong understanding of GxP practices.

Qualifications

• 12+ years of relevant GxP bioanalytical experience with a Bachelor's degree
• 8+ years of relevant GxP bioanalytical experience with a Master’s degree
• Strong knowledge of GxP regulations, method development, qualification, validation, and regulated analysis
• Hands-on experience with LC-MS/MS, LC-FL, hybrid assays, immunoassays or related platforms
• Experience serving as Principal Investigator for regulated nonclinical/clinical bioanalytical studies is preferred

Responsibilities

• Serve as Principal Investigator for bioanalytical method qualification, validation, and sample analysis
• Design, develop, optimize, and troubleshoot bioanalytical methods
• Review, interpret, and document analytical data
• Investigate out-of-specification results and recommend corrective actions
• Maintain and troubleshoot laboratory instrumentation and ensure compliance
• Plan and execute studies, track milestones, and manage timelines
• Collaborate with cross-functional teams to support program objectives
• Contribute to implementing new analytical technologies and workflows
• Develop and improve SOPs and laboratory procedures to ensure regulatory standards

Skills

GxP bioanalytical experience

Bioanalytical method development

Data management

Scientific writing

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry

Master’s degree in Chemistry

Tools

LC-MS/MS

LC-FL

Hybrid assays

Immunoassays

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a Scientist to join the GLP Bioanalytical group within the Clinical Pharmacology and DMPK department in Madison, WI.

You will lead bioanalytical method development, transfer, qualification, validation, and sample analysis for pharmacokinetic studies across development stages. The successful candidate will have hands-on LC-MS/MS, LC-FL, hybrid assays, and immunoassays experience, with a strong understanding of GxP practices.