Product Quality Director - Hybrid Modalities

Amgen seeks a Product Quality Director to lead quality strategy for hybrid modality programs, including complex molecules like antibody-drug conjugates. This role requires scientific expertise in manufacturing, regulatory compliance, and cross-functional collaboration to support product development and commercial operations.

Responsibilities

• Lead cross-functional product quality efforts for hybrid modality programs including specifications, comparability, and stability programs
• Provide scientific oversight of pivotal and commercial products with data review and GMP document ownership
• Manage and mentor a Product Quality Team while providing technical guidance on complex manufacturing and process issues
• Communicate complex quality and regulatory information to leadership, peers, and regulatory agencies including inspectional support
• Drive operationally efficient processes and corporate alignment across international manufacturing sites

Requirements

• Doctorate with 4+ years quality/operations/manufacturing experience, or Master's with 7+ years, or Bachelor's with 9+ years
• Advanced degree in chemistry, biochemistry, biology, or biotechnology sciences preferred
• 8+ years pharmaceutical experience with increasing responsibility in quality or related functions
• 6+ years direct GMP regulated environment experience
• 4+ years managing and leading teams, projects, or programs
• Expertise in large and small molecule development, bioconjugate testing, and analytical methods
• Experience authoring or reviewing regulatory filings and leading non-conformance investigations