Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Arrowhead Pharmaceuticals is seeking a Scientist II, Quality Control to join our growing Quality organization in Verona, Wisconsin. In this role, you will provide technical leadership for analytical method validation, method transfer, and quality control testing supporting the development and commercialization of innovative RNAi therapeutics.
As a Scientist II, you will lead analytical projects, serve as a technical expert for complex laboratory investigations, and collaborate closely with Analytical Development, Manufacturing, and Quality teams. You'll drive scientific decision-making, mentor junior scientists, and contribute to continuous improvement initiatives that strengthen our analytical capabilities and support product quality throughout the development lifecycle.
Lead analytical method validation, method transfer, and Quality Control testing activities for raw materials, in-process samples, drug substances, drug products, and stability programs.
Independently manage analytical project timelines and deliverables while partnering with Analytical Development, Manufacturing, and cross-functional stakeholders.
Serve as the Analytical Project Coordinator for method validation, technical transfer, and analytical support activities.
Design, execute, and interpret complex analytical experiments to support process development, investigations, and product lifecycle activities.
Analyze scientific data, identify trends, investigate atypical results, and recommend appropriate follow-up actions.
Support optimization and continuous improvement of analytical methods throughout all phases of API and drug product development.
Prepare technical documentation, including:
Analytical methods
Validation protocols and reports
Development reports
SOPs
Scientific presentations
Perform technical review of analytical data generated by other QC scientists and analysts.
Support Out-of-Specification (OOS) investigations, deviations, and laboratory investigations with minimal supervision.
Lead scientific discussions and technical problem-solving sessions with internal and external stakeholders.
Mentor and provide technical guidance to junior scientists and laboratory staff.
Ensure all laboratory activities comply with cGMP requirements, ICH guidelines, and internal Quality procedures.
Bachelor's degree in Chemistry or a related scientific discipline with 8+ years of relevant laboratory experience, or Master's degree in Chemistry or a related scientific discipline with 5+ years of relevant laboratory experience.
Fully knowledgeable of cGMP and ICH laboratory requirements and operations.
Strong attention to detail and good documentation practices; comfort working against defined hold times and turnaround targets.
Prior experience testing oligonucleotides, peptides, or other synthetic biomolecules.
Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing.
Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab.
Fully knowledgeable of cGMP and ICH laboratory requirements and operations.
Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices.
Wisconsin pay range
$105,000—$120,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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Originally posted by Arrowhead Pharmaceuticals. View original posting
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