- Location
- Madison, Wisconsin, United States · Madison, WI
- Department
- Education
- Seniority
- Senior
- Education
- PhD
Description
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.
The Position
Arrowhead is seeking a highly motivated and experienced Senior Scientist on Analytical Chemistry to lead analytical method development, characterization, and testing activities supporting pharmaceutical development programs. This role will be responsible for developing and qualifying analytical methods, overseeing analytical activities performed at contract development and manufacturing organizations (CDMOs), and authoring analytical sections of regulatory submissions. The successful candidate will serve as a technical expert in Antibody oligo conjugate (AOC) drug characterization and will collaborate closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
Responsibilities
- Design, develop, optimize, qualify, and transfer analytical methods to support development and manufacturing activities.
- Lead analytical characterization studies for drug substances, intermediates, and related materials.
- Develop and execute analytical strategies to assess product identity, purity, potency, impurities, and stability.
- Interpret analytical data, investigate trends, and provide scientific recommendations to project teams.
- Support method lifecycle management, troubleshooting, and continuous improvement activities.
- Provide scientific and technical oversight of analytical development, testing, method qualification, and transfer activities conducted at CDMOs.
- Review protocols, reports, deviations, investigations, and technical documents generated by external partners.
- Monitor project timelines, deliverables, and analytical performance to ensure project objectives are achieved.
- Serve as the primary analytical subject matter expert during interactions with CDMOs and contract testing laboratories.
- Collaborate with Process Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and CMC teams to support program milestones.
- Contribute to analytical control strategy development and product specification setting.
- Present analytical findings and recommendations to internal teams and management.
- Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, BLAs, and other global regulatory filings.
- Support responses to regulatory agency questions and inspections.
- Ensure analytical activities comply with applicable GMP, ICH, FDA, EMA, and other regulatory requirements.
- Participate in quality investigations, change controls, risk assessments, and CAPA activities as needed.
Requirements
- PhD in analytical chemistry or close related fields with 5+ years pharmaceutical relevant industry experience; or M.S. with 8+ years of relevant industry experience; or B.S. with 10+ years of relevant industry experience.
- Extensive knowledge of Oligo, mAb, ADC or AOC-related analytical techniques and applications.
- Demonstrated expertise with chromatographic methods, including HPLC, UHPLC, and related analytical platforms.
- Experience with GMP-regulated analytical development and testing environments.
- Strong understanding of method transfer, validation, and lifecycle management principles.
- Experience authoring analytical CMC documentation for regulatory submissions.
- Strong scientific problem-solving and troubleshooting skills.
- Excellent technical writing and communication abilities.
- Ability to manage multiple projects in a fast-paced environment.
- Strong organizational skills and attention to detail.
- Effective collaborator with demonstrated ability to influence cross-functional teams and external partners.
Preferred
- Hands-on Experience with Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS) is preferred but not necessary.
- Experience supporting biologics, oligonucleotides, ADC, AOC or other complex modalities.
- Prior experience managing external laboratories and CDMOs.
- Familiarity with ICH guidelines and global regulatory expectations.
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.