Sr. Scientist, GLP Bioanalysis

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

The Sr. Scientist will lead method development, validation, and sample analysis in support of GLP toxicokinetic and GCP pharmacokinetic studies. The Sr. Scientist will have expertise with instrument control software and Watson LIMS, LC-MS, and HPLC-FL analytical platforms and is well versed in regulated bioanalysis. This individual will lead a team of bioanalytical scientists, and provide training and expertise to less experienced scientists. The Sr. Scientist will join a team of highly motivated and professional scientists and contribute to the success of Arrowhead development programs.

Responsibilities

• Lead and mentor a team of bioanalytical scientists, providing technical and career development guidance, including managerial duties such as performance goals, reviews, and talent development
• Develop and optimize methods for validation, ability to troubleshoot complex assay issues
• Perform method validations and sample analysis via HPLC-FL
• Revise/review SOPs and document templates related to GLP bioanalysis
• Develop a training program and lead training of junior scientists
• Ensure work is compliant per GLP/GCP regulatory requirements and stay up-to-date on relevant regulations
• Lead lab organization and evaluate and maintain instrument calibration and performance
• Primary Watson LIMS and OpenLab user, ensure maintenance and user requirements are met
• Take on role as Principal Investigator for toxicokinetic GLP studies
• Conduct peer review of data, protocols, and reports
• Effectively manage workload and monitor and evaluate team completion of tasks and projects
• Works collaboratively with cross-functional teams (Program Management, Clinical Operations, DMPK, QA, QC, Metrology, Regulatory and others as needed) to develop and meet project goals, deliverables, and timelines
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams
• Multi-task across several projects and manage time effectively to achieve results
• Adhere to safe laboratory practices

Requirements

• Minimum BS degree with 10+ years or MS with 7+ years or PhD with 5+ years of relevant experience in the pharmaceutical/CRO industry
• Demonstrated method development experience with various analytical platforms and deep expertise with LC-MS and LC-FL
• Demonstrated method validation and sample analysis in a regulated environment
• Demonstrated expertise in LIMS system and instrument control software
• Demonstrated project and time management
• Experience leading and 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

Wisconsin pay range

$120,000-$140,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

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

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