The Position Arrowhead Pharmaceuticals is seeking a Scientist to join the GLP Bioanalytical group within the Clinical Pharmacology and DMPK department. This individual will support Arrowhead's drug development programs by leading bioanalytical method development, transfer, qualification, validation, and sample analysis for pharmacokinetic studies across early- and late-stage development.
The successful candidate will have hands-on experience with bioanalytical platforms such as LC-MS/MS, LC-FL, hybrid assays, and immunoassays, along with a strong understanding of GxP bioanalytical practices. This role partners closely with cross-functional teams to ensure high-quality bioanalytical support while meeting project timelines. The Scientist will join a collaborative team of experienced scientists and play an important role in advancing Arrowhead's clinical and nonclinical development programs
Responsibilities
- Serve as Principal Investigator for bioanalytical method qualification, validation, and nonclinical and clinical sample analysis using LC-MS/MS, LC-FL, hybrid assays, immunoassays, and other analytical platforms.
- Design, develop, optimize, and troubleshoot bioanalytical methods with minimal supervision.
- Perform scientific review, interpretation, and documentation of analytical data.
- Investigate unexpected or out-of-specification results and recommend appropriate corrective actions.
- Operate, maintain, and troubleshoot laboratory instrumentation while ensuring laboratory organization and compliance.
- Plan and execute studies while tracking project milestones, communicating progress, and identifying potential risks to timelines.
- Collaborate with cross-functional teams to coordinate bioanalytical activities that support program objectives.
- Contribute to the evaluation, implementation, and continuous improvement of new analytical technologies and laboratory workflows.
- Develop and improve laboratory procedures, SOPs, and best practices to ensure regulatory compliance and operational efficiency.
- Maintain compliance with GxP regulations, Good Documentation Practices (GDP), and laboratory safety standards.
- Effectively manage multiple projects and priorities in a fast-paced environment.
Requirements- Bachelor's degree in Chemistry or a related scientific discipline with 12+ years of relevant GxP bioanalytical experience; or Master's degree in Chemistry or a related scientific discipline with 8+ years of relevant GxP bioanalytical experience.
- Strong knowledge of GxP regulations, bioanalytical method development, qualification, validation, and regulated sample analysis.
- Hands-on experience with LC-MS/MS, LC-FL, hybrid assays, immunoassays, or related bioanalytical platforms.
- Experience serving as Principal Investigator for regulated nonclinical and/or clinical bioanalytical studies is highly preferred.
- Demonstrated experience troubleshooting analytical methods and resolving technical challenges.
- Excellent documentation, organizational, and data management skills.
- Strong scientific judgment with the ability to analyze, interpret, and communicate complex data.
- Excellent written and verbal communication skills.
- Self-motivated, collaborative team player who thrives in a fast-paced, multidisciplinary environment.
Preferred- Experience training or mentoring scientists.
- Experience leading laboratory workflow improvements and process optimization initiatives.
- Experience with regulated sample management in a GxP environment.
- Experience implementing new analytical technologies or laboratory systems.
Wisconsin pay range
$100,000-$110,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
