<p>The Position</p> <p>Arrowhead Pharmaceuticals is seeking a Scientist I/II to join the BioAnalytical Development team within the Clinical Pharmacology and DMPK Department. The successful candidate will play a key role in the development and validation of bioanalytical ligand-binding assays to support immunogenicity assessment (ADA), and in the execution of bioanalytical sample analysis across nonclinical, early- and late-phase clinical programs. The candidate will also support internal data review and inventory management. The ideal candidate will have hands-on experience with Mesoscale Discovery (MSD) and various analytical platforms, along with a strong foundation in GxP bioanalysis. The individual will join a team of highly motivated and experienced scientists and will contribute directly to the success of Arrowhead's therapeutic programs.</p> <p>Responsibilities</p> <ul> <li>Work independently or in collaboration with senior scientists to support project planning for bioanalytical activities, including critical reagent generation and the ADA method development, optimization, and qualification. </li><li>Lead assigned projects, perform or oversee non-GxP and GxP ADA validations and sample analysis from early to late development, both internally and with external partners. Conduct data analysis and interpretation as needed. </li><li>Track progress against project timelines, prepare routine status updates, and effectively communicate progress, challenges, and mitigations to management and cross-functional project teams. </li><li>Collaborate and support internal bioanalysis team on data review and inventory management </li><li>Stay current with evolving methodologies, and regulatory expectations related to ADA assessment, particularly for oligonucleotide therapeutics. </li><li>Manage multiple projects concurrently and prioritize work effectively in a fast-paced environment. </li></ul> <p>Requirements</p> <ul> <li>Bachelor's degree with 5+ years, or Master's degree with 3+ years, of relevant experience in the pharmaceutical or CRO industry. </li><li>Demonstrated experience in method development using diverse analytical platforms, with deep expertise in ligand-binding assays for immunogenicity assessment. </li><li>Proven project-management skills with the ability to prioritize multiple tasks and meet deadlines. </li><li>Strong organizational skills with excellent attention to detail, and adherence to good documentation practices. </li><li>Excellent oral and written communication skills. </li><li>Self-motivated team player who thrives in a fast-paced, dynamic, multidisciplinary, and matrixed environment. </li></ul> <p>Preferred</p> <ul> <li>Hands-on experience with a range of analytical platforms, including MSD, ELISA, Gyros, Luminex, LC-FL, and qPCR etc., ideally within the context of oligonucleotide therapeutics. </li><li>Experience and familiarity with GxP regulations and industry best practices for method validation, sample handling, and bioanalytical workflows. </li><li>Experience with electronic laboratory notebooks and LIMS. </li></ul>