Senior Scientist II, Discovery Analytical Chemistry

Arrowhead Pharmaceuticals•Madison, WI

19h•$130,000 - $150,000

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing the genes that cause them. They utilize a broad portfolio of RNA chemistries and delivery modes to trigger RNA interference (RNAi), leading to rapid, deep, and durable knockdown of target genes. Arrowhead's therapies leverage the natural RNAi pathway to inhibit specific gene expression. The company is dedicated to developing innovative drugs for diseases with a genetic basis, particularly those characterized by the overproduction of disease-involved proteins. Their versatile RNAi technologies have the potential to address conditions in virtually any therapeutic area and target diseases not addressable by traditional small molecules and biologics. Arrowhead is a leader in applying RNAi beyond the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. Arrowhead's corporate headquarters are located 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. The company fosters a culture of nimble, science-driven innovators collaborating to bring new therapies to patients in need. Arrowhead is seeking a highly motivated and experienced Senior Scientist in Analytical Chemistry to lead analytical method development, characterization, and testing activities for pharmaceutical development programs. This role involves developing and qualifying analytical methods, overseeing analytical activities at contract development and manufacturing organizations (CDMOs), and authoring analytical sections of regulatory submissions. The successful candidate will be a technical expert in Antibody oligo conjugate (AOC) drug characterization and will collaborate closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.

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.
Candidates must have current, valid authorization to work in the country where this role is located.

Nice To Haves

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.

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.