Lead Analytical Method Validation & Transfer Manager

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 170,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager to lead Analytical Method Validation within the QC department. The role guides validation and transfer for complex oligonucleotide analyses, ensuring compliance with ICH, USP, and other compendial requirements.

Strong SME presence in cross-functional discussions, project timelines, and strategic data interpretation is required. This position is based in Madison, WI, with competitive benefits and a focus on robust analytical performance.

Qualifications

• MS in Chemistry or related field with 6+ years lab exp.
• Direct experience with analytical techniques (LC-MS, GC, NMR, FTIR).
• GMP/cGMP knowledge and regulatory familiarity.

Responsibilities

• Plan, author and execute method validation protocols and reports.
• Lead technical transfer of analytical methods between sites and CROs.
• Oversee validation for oligonucleotide purity and impurity testing.
• Coordinate with QA, Regulatory Affairs and Manufacturing on validation activities.
• Provide hands-on troubleshooting and data review of analytical results.

Skills

Leadership

Analytical methods

GMP compliance

LC-MS

QMS

Project management

Transfer/validation

Regulatory interactions

Education

M.S. in Chemistry

B.S. in Chemistry

Tools

Empower

OpenLab

LIMS

Job description

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager to lead Analytical Method Validation within the QC department. The role guides validation and transfer for complex oligonucleotide analyses, ensuring compliance with ICH, USP, and other compendial requirements.

Strong SME presence in cross-functional discussions, project timelines, and strategic data interpretation is required. This position is based in Madison, WI, with competitive benefits and a focus on robust analytical performance.