Clinical Pharmacology and DMPK
Sr. Scientist, GLP Bioanalysis
Office Location: Madison, WI
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/Senior Scientist to join the Bioanalytical group within the Clinical Pharmacology Department. The successful candidate will focus on internal bioanalytical method development and qualification of biomarker assays and oversee bioanalytical method transfer, validation, and sample analysis for pharmacokinetic and biomarkers studies for early and late development phase programs. S/He will have expertise with various analytical platforms including LC/MS/MS, LC-FL, immunoassays 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
- Lead assigned projects, provide oversight of outsourced GxP bioanalytical validations and sample analysis from early to late development for pharmacokinetic and biomarkers studies
- Track progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams
- Perform scientific and data review, data analysis and interpretation and troubleshoot complex method issues as needed
- Lead method development and qualification of bioanalytical assays via LC-MS/MS and immunoassays or other platforms for clinical biomarker studies
- Explore new analytical platforms and lead lab organization and setup for biomarkers
- Setup and maintain lab instrumentation for biomarkers
- Train other group members in biomarkers method development and qualification and biomarkers/PK project oversight
- Effectively manage workload with minimal supervision
- Multi-task across several projects and manage time effectively to achieve results
- Follow SOPs and stay up to date on regulations
- Adhere to Good Documentation Practices
- Adhere to safe laboratory practices
Requirements:
- Ph.D. in Chemistry (or related field) with 5+ years of relevant GxP experience
- Familiarity with GxP regulations and approaches to method validations, sample analysis, and data processing
- Demonstrated method development experience with various analytical platforms and deep expertise with LC-MS/MS and immunoassays
- Demonstrated project and time management
- 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
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.