Scientist/Sr. Scientist, Bioanalytical (ADA)

Full Time On-Site/Hybrid Preclinical Research Scientist Apply for this Job Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. 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/Sr. Scientist to join the BioAnalytical Development team within the Clinical Pharmacology Department. The successful candidate will primarily focus on bioanalytical method development/optimization/validation of ligand binding assays in support of immunogenicity assessment and biomarkers and sample analysis, for early and late phase development programs. S/He will have expertise with Mesoscale Discovery and various analytical platforms and is well versed in GxP bioanalysis. S/He will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead programs.

Responsibilities

• Contribute to project planning for bioanalytical efforts and lead critical reagents generation and method development and qualification of ligand binding assays
• Lead assigned projects, provide oversight of non-GxP and GxP ligand binding assay validations and sample analysis from early to late development, internally and externally
• Stay up to date with the latest methods pertaining to ADA assessment
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams
• Represents the function on a Project Team and present findings in team meetings
• Multi-task across several projects and manage time effectively to achieve results
• Train other group members in bioanalytical method development, qualification, analysis and project oversight
• Perform data analysis and interpretation
• Conduct peer review of data
• Setup and maintain lab instrumentation
• Evaluate assay and instrument performance, ability to troubleshoot complex method issues
• Maintain a well-documented laboratory notebook
• Effectively manage workload with minimal supervision
• Adhere to safe laboratory practices

Requirements:

• B.S. in Chemistry (or related field) with 8+ years of relevant GxP experience, M.S. in Chemistry (or related field) with 6+ years of relevant GxP experience, Ph.D. in Chemistry (or related field) with 2-5 years of relevant GxP experience.
• Demonstrated method development experience with various analytical platforms and deep expertise with ligand binding assays for immunogenicity and biomarkers
• Demonstrated project and time management and ability to prioritize work and meet target deadlines
• Experience with training other scientists and leading lab organization and processes
• Good documentation practices with excellent organization and attention to detail
• Demonstrated innovation, creativity and resilience in problem solving
• Excellent oral and written communication skills
• Self-motivated team player with the ability to thrive in a fast paced, dynamic, multi-disciplinary, matrixed environment

Preferred:

• Experience with a wide range of analytical techniques such as Mesoscale Discovery, Gyros, Luminex and ELISAs
• Experience and familiarity with GxP regulations and approaches to method validations, sample handling and processing
• Experience with electronic lab notebooks and LIMS system
• Deep familiarity with the FDA bioanalytical method validation guidance
• Outstanding project management skills

Wisconsin pay range

$90,000—$150,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.