Specialist Stability

Join Amgen’s Mission of Serving Patients. The Specialist Stability role will provide critical support to a Product Quality Team (PQT) by managing the stability program for late stage clinical and commercial products and providing data management support for additional aspects of the PQT and regulatory reporting.

Requirements

• Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)
• Author and maintain GMP technical documents and stability reports in compliant systems
• Provide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)
• Collate, review, verify, and archive GMP stability and product quality data
• Coordinate stability study starts and sample requests with global teams
• Participate in audits and inspections across multiple sites, ensuring readiness and compliance
• Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes
• Mentor and train staff, sharing expertise to strengthen team capabilities

Benefits

• Competitive and comprehensive Total Rewards Plans
• Inclusive environment of diverse, ethical, committed and highly accomplished people
• Equal Opportunity employer
• Reasonable accommodation for individuals with disabilities
• Collaborative culture
• Professional and personal growth and well-being