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.
Wisconsin pay range
$130,000-$150,000 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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