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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.
Job Responsibility:
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
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
Track progress against project timelines, prepare routine status updates, and effectively communicate progress, challenges, and mitigations to management and cross‑functional project teams
Collaborate and support internal bioanalysis team on data review and inventory management
Stay current with evolving methodologies, and regulatory expectations related to ADA assessment, particularly for oligonucleotide therapeutics
Manage multiple projects concurrently and prioritize work effectively in a fast‑paced environment
Requirements:
Bachelor’s degree with 5+ years, or Master’s degree with 3+ years, of relevant experience in the pharmaceutical or CRO industry
Demonstrated experience in method development using diverse analytical platforms, with deep expertise in ligand‑binding assays for immunogenicity assessment
Proven project‑management skills with the ability to prioritize multiple tasks and meet deadlines
Strong organizational skills with excellent attention to detail, and adherence to good documentation practices
Excellent oral and written communication skills
Self‑motivated team player who thrives in a fast-paced, dynamic, multidisciplinary, and matrixed environment
Nice to have:
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
Experience and familiarity with GxP regulations and industry best practices for method validation, sample handling, and bioanalytical workflows
Experience with electronic laboratory notebooks and LIMS
What we offer:
competitive salaries and an excellent benefit package