Global Stability & Retains Program Lead

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 150,000 - 190,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Senior Manager to lead the Global Sample Stability and Retains Program within the Quality Control unit at the Verona site in Wisconsin.

You will design and oversee stability programs across development and commercial operations, ensuring regulatory compliance and audit readiness. You will manage a team of stability professionals, interact with Regulatory Affairs, and coordinate with internal sites, CMOs, and CTLs to support submissions and inspections

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related discipline required; advanced degree preferred.
• Minimum 8–10 years of experience in pharmaceutical/biotech QA/QC/CMC with global stability program management.
• 3–5 years of people management experience leading a team.
• Experience supporting clinical and global commercial products preferred.
• RNAi/oligonucleotide/complex modality experience is a plus.

Responsibilities

• Establish and manage a global stability and retain sample program per US/EU regs across materials and finished goods.
• Develop, review, and approve stability protocols and study designs; ensure studies are executed on schedule.
• Oversee data trending and analysis to support shelf-life and regulatory filings.
• Support annual product stability reviews and regulatory submissions.
• Lead and develop the stability and retain team across internal sites and CMOs.

Skills

Project management

Leadership

Communication

Regulatory knowledge

Quality Assurance

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related discipline

Master’s degree preferred

Tools

LIMS

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a Senior Manager to lead the Global Sample Stability and Retains Program within the Quality Control unit at the Verona site in Wisconsin.

You will design and oversee stability programs across development and commercial operations, ensuring regulatory compliance and audit readiness. You will manage a team of stability professionals, interact with Regulatory Affairs, and coordinate with internal sites, CMOs, and CTLs to support submissions and inspections