Senior Analytical Method Validation Lead

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

Job summary

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Senior Analytical Method Validation Manager to lead a QC team focused on analytical method validation, transfer, and development for oligonucleotide products.

You will ensure methods meet ICH/USP guidelines, provide SME input, and collaborate across QA, Regulatory, Manufacturing, and external partners. The role emphasizes hands-on leadership, regulatory readiness, and robust data-driven decision making within a GMP framework, with a

Qualifications

• Plan, author, and execute analytical method validation protocols and reports.
• Lead technical transfer of analytical methods between sites and partners.
• Oversee validation for analytical techniques supporting oligonucleotide testing.
• Present validation strategies and data to QA, Regulatory, and Manufacturing.
• Lead or coordinate Analytical Validation and technical transfer projects.

Responsibilities

• Plan, author, and execute analytical method validation protocols and reports in line with SOPs and ICH Q2(R2).
• Lead technical transfer of methods between sites and contract partners.
• Oversee validation for oligonucleotide purity/impurity testing (Identity).
• Collaborate with QA, Regulatory Affairs, Manufacturing on strategy and data.
• Manage timelines and deliverables with Analytical Development and manufacturing teams.
• Provide troubleshooting for methods performance and OOS/OOT investigations.
• Write analytical test methods, development reports, and protocols.

Skills

Analytical method validation

Leadership

Regulatory compliance

Cross-functional collaboration

Project management

Education

MS in Chemistry

BS in Chemistry

Tools

LC-MS

NMR

GC

FTIR

ICP-MS

Raman

UHPLC

LIMS

Empower

OpenLab

Job description

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Senior Analytical Method Validation Manager to lead a QC team focused on analytical method validation, transfer, and development for oligonucleotide products.

You will ensure methods meet ICH/USP guidelines, provide SME input, and collaborate across QA, Regulatory, Manufacturing, and external partners. The role emphasizes hands-on leadership, regulatory readiness, and robust data-driven decision making within a GMP framework, with a