Scientist II, GLP Bioanalysis

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. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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; orMaster'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.

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.