Scientist, Bioanalytical

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 to join the Bioanalytical group within the Clinical Pharmacology Department. The successful candidate will focus on bioanalytical method transfer, validation, and sample analysis for early and late development phase programs. S/He will have expertise with LC/MS/MS and LC-FL and is well versed in GxP bioanalysis. S/He will coordinate and monitor bioanalytical activities outsourced to external partners. S/He will interface with the clinical teams to coordinate sample analysis according to the study needs and timelines. S/He will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead development programs. Responsibilities Act as the Bioanalytical Principal Investigator for analysis performed at Arrowhead and as the Bioanalytical Study Monitor for outsourced studies Lead assigned projects, provide oversight of GxP bioanalytical validations and sample analysis from early to late development, both internally and externally Perform quantitative analysis of oligonucleotides and its metabolites in a variety of biological matrices (fluids and tissues) in support of toxicokinetics, pharmacokinetics and biodistribution studies. This includes the sample preparation, instrumentation analysis, and LIMS data output. Evaluate assay and instrument performance. Ability to troubleshoot complex method issues and collaborate with scientists at both Arrowhead and at CROs Support clinical teams by providing sample collection requirements, monitoring shipment schedules, and coordinating analysis and reporting timelines with CRO Provide CROs with information to initiate validations and sample analysis. Such as method transfer guidelines, protocol, reference material, contracting, timelines, etc. Perform scientific and peer review on data generated at both internal labs and at CRO Mediate and manage contact and communication with internal customers and external partners Multitask across several projects and manage time effectively to achieve results Track progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams Train others in bioanalytical method validation, analysis, and project oversight Setup and maintain lab instrumentation Adhere to Good Documentation Practices Adhere to safe laboratory practices Support the development of process and procedures required for the implementation of and in-house regulated GLP lab Requirements: B.S. in Chemistry (or related field) with 5+ years of relevant GxP experience, M.S. in Chemistry (or related field) with 3+ years of relevant GxP experience, Ph.D. in Chemistry (or related field) with 2+ years of relevant GxP experience Expertise with LC/MS/MS and/or LC/FL Familiarity with GxP regulations and approaches to method validations, sample handling, and data processing 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 Computer System Validations and SOP development Experience with LIMS and chromatography software Deep familiarity with the ICH M10 guidance Project management experience Wisconsin pay range $95,000—$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. Website