Senior Scientist II, Discovery Analytical Chemistry
Arrowhead Pharmaceuticals
August 06, 2026
Remote friendly (Madison, WI)
United States
Clinical Research and Development
The Position:
Senior Scientist on Analytical Chemistry to lead analytical method development, characterization, and testing activities supporting pharmaceutical development programs. Serve as technical expert in Antibody oligo conjugate (AOC) drug characterization; collaborate with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
Responsibilities:
- Design, develop, optimize, qualify, and transfer analytical methods to support development and manufacturing.
- Lead analytical characterization for drug substances, intermediates, and related materials.
- Develop and execute analytical strategies for identity, purity, potency, impurities, and stability.
- Interpret analytical data, investigate trends, and recommend actions.
- Support method lifecycle management, troubleshooting, and continuous improvement.
- Provide oversight of analytical development, testing, qualification, and transfer at CDMOs.
- Review protocols, reports, deviations, investigations, and technical documents from external partners.
- Monitor timelines/deliverables and analytical performance.
- Act as primary analytical SME with CDMOs and contract testing laboratories.
- Collaborate across Process Development, Manufacturing, Quality Control/Assurance, Regulatory Affairs, and CMC.
- Support analytical control strategy and product specification setting.
- Present findings to internal teams.
- Author/review analytical sections of INDs, IMPDs, CTAs, BLAs, and other filings.
- Support regulatory responses and inspections.
- Ensure compliance with GMP, ICH, FDA, EMA, and other requirements.
- Participate in quality investigations, change controls, risk assessments, and CAPA.
Requirements:
- PhD (5+ years) or MS (8+ years) or BS (10+ years) in analytical chemistry or closely related field.
- Extensive knowledge of oligo, mAb, ADC, or AOC analytical techniques.
- Expertise in chromatographic methods (HPLC, UHPLC).
- Experience in GMP-regulated analytical development/testing.
- Knowledge of method transfer, validation, and lifecycle management.
- Experience authoring analytical CMC documentation for regulatory submissions.
- Strong problem-solving/troubleshooting; technical writing/communication.
- Ability to manage multiple projects; strong organization and attention to detail.
Preferred:
- SEC-MALS experience (preferred but not required).
- Experience with biologics/oligonucleotides/ADC/AOC or other complex modalities.
- Experience managing external labs and CDMOs.
- Familiarity with ICH and global regulatory expectations.
Benefits/Compensation:
- Wisconsin pay range: $130,000 USD - $150,000 USD.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.
Senior Scientist on Analytical Chemistry to lead analytical method development, characterization, and testing activities supporting pharmaceutical development programs. Serve as technical expert in Antibody oligo conjugate (AOC) drug characterization; collaborate with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.
Responsibilities:
- Design, develop, optimize, qualify, and transfer analytical methods to support development and manufacturing.
- Lead analytical characterization for drug substances, intermediates, and related materials.
- Develop and execute analytical strategies for identity, purity, potency, impurities, and stability.
- Interpret analytical data, investigate trends, and recommend actions.
- Support method lifecycle management, troubleshooting, and continuous improvement.
- Provide oversight of analytical development, testing, qualification, and transfer at CDMOs.
- Review protocols, reports, deviations, investigations, and technical documents from external partners.
- Monitor timelines/deliverables and analytical performance.
- Act as primary analytical SME with CDMOs and contract testing laboratories.
- Collaborate across Process Development, Manufacturing, Quality Control/Assurance, Regulatory Affairs, and CMC.
- Support analytical control strategy and product specification setting.
- Present findings to internal teams.
- Author/review analytical sections of INDs, IMPDs, CTAs, BLAs, and other filings.
- Support regulatory responses and inspections.
- Ensure compliance with GMP, ICH, FDA, EMA, and other requirements.
- Participate in quality investigations, change controls, risk assessments, and CAPA.
Requirements:
- PhD (5+ years) or MS (8+ years) or BS (10+ years) in analytical chemistry or closely related field.
- Extensive knowledge of oligo, mAb, ADC, or AOC analytical techniques.
- Expertise in chromatographic methods (HPLC, UHPLC).
- Experience in GMP-regulated analytical development/testing.
- Knowledge of method transfer, validation, and lifecycle management.
- Experience authoring analytical CMC documentation for regulatory submissions.
- Strong problem-solving/troubleshooting; technical writing/communication.
- Ability to manage multiple projects; strong organization and attention to detail.
Preferred:
- SEC-MALS experience (preferred but not required).
- Experience with biologics/oligonucleotides/ADC/AOC or other complex modalities.
- Experience managing external labs and CDMOs.
- Familiarity with ICH and global regulatory expectations.
Benefits/Compensation:
- Wisconsin pay range: $130,000 USD - $150,000 USD.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.