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; 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.
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.
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Skills Required
- Bachelor's degree in Chemistry or related discipline with 12+ years of relevant GxP bioanalytical experience OR Master's degree in Chemistry or related 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, and immunoassays.
- Demonstrated experience troubleshooting analytical methods and resolving technical challenges.
- Excellent documentation, organizational, and data management skills (Good Documentation Practices).
- Excellent written and verbal communication skills.
- Self-motivated, collaborative team player able to manage multiple projects and priorities.
- Experience serving as Principal Investigator for regulated nonclinical and/or clinical bioanalytical studies.
- 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.
- Current, valid authorization to work in the country where this role is located.
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What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
