Analytical Method Validation Lead - Senior Manager

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 140,000 - 160,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking an Analytical Method Validation Sr. Manager in Wisconsin to lead a QC team in planning, executing, and overseeing analytical method validation and technical transfer for oligonucleotide testing across drug substances and products.

The role requires a strong GMP/ICH/USP background, hands-on leadership, and collaboration with QA, Regulatory Affairs, Manufacturing, and external partners to ensure robust, reproducible methods and timely project delivery.

Qualifications

• M.S. in Chemistry (or related field) with 6+ years of lab experience or B.S. with 8+ years of lab experience.
• Direct experience with analytical techniques (LC-MS, AEX, IP-RP UHPLC, GC, NMR, FTIR, ICP-MS, Raman).
• Familiar with cGMP policies and validations; experience with complex oligonucleotides is required.

Responsibilities

• Plan, author, and execute analytical method validation protocols and reports.
• Lead technical transfer of analytical methods between sites and partners.
• Oversee validation/transfer activities for oligonucleotide purity/impurity testing and Identity.
• Present validation strategies and data to QA, Regulatory, Manufacturing, and external partners.
• Coordinate analytical requirements and provide accurate analytical results.
• Support optimization and troubleshooting of analytical methods.

Education

M.S. in Chemistry (or related field)

B.S. in Chemistry (or related field)

Tools

Empower

OpenLab

LIMS

Job description

Arrowhead Pharmaceuticals, Inc. is seeking an Analytical Method Validation Sr. Manager in Wisconsin to lead a QC team in planning, executing, and overseeing analytical method validation and technical transfer for oligonucleotide testing across drug substances and products.

The role requires a strong GMP/ICH/USP background, hands-on leadership, and collaboration with QA, Regulatory Affairs, Manufacturing, and external partners to ensure robust, reproducible methods and timely project delivery.