Arrowhead Pharmaceuticals

Senior Scientist II, Discovery Analytical Chemistry

Madison, Wisconsin, United States · Senior

Sponsorship not specified$130k-$150kDetected 7 days ago

GMPFDA RegulatoryResearchMass SpectrometryAnimal StudiesCommunicationProblem SolvingWritingOrganizational SkillsRegulatory Affairs

About the role

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.

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.
Support method lifecycle management, troubleshooting, and continuous improvement activities.
Review protocols, reports, deviations, investigations, and technical documents generated by external partners.
Collaborate with Process Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and CMC teams to support program milestones.
Support responses to regulatory agency questions and inspections.

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.
Experience supporting biologics, oligonucleotides, ADC, AOC or other complex modalities.
Familiarity with ICH guidelines and global regulatory expectations.

Hands-on Experience with Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS) is preferred but not necessary.

Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.