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Senior Manager, Global Sample Stability and Retains Program

Arrowhead Pharmaceuticals
September 05, 2026
Full-time
On-site
Madison, WI
Operations
Role: Senior Manager leading the Global Sample Stability and Retains Program within Arrowhead's Quality Control team, based at the Verona site. Responsibilities: design, implement, and oversee stability programs for raw materials, drug substance, drug product, and finished goods across all development and commercial phases, ensuring compliance with global regulations (FDA, EMA, MHRA, PMDA, TGA, Health Canada). Manage stability studies, data trending, shelf-life justifications, and reference standard lifecycle activities. Lead and develop a team of stability and retain professionals, supporting regulatory filings and audits. Requirements: Bachelor's in Chemistry, Pharmaceutical Sciences, Biology, or related; 8–10 years in pharmaceutical/biotech QA/QC/CMC with stability program experience; 3–5 years of leadership. Experience supporting clinical (IND) and commercial products preferred, especially with complex modalities like RNAi or biologics. Knowledge of global stability/regulatory guidance and experience with LIMS and data trending techniques are highly valued. High-Value: focus on stability, retain sample management, reference standard lifecycle, global regulatory compliance, and leadership in a biopharma setting. Work Setup: onsite at Verona, WI; salary range $140K–$160K.