Manager - Stability

Responsibilities

• Directly supervise Quality staff supporting Product Quality Teams and regulatory submissions
• Manage staff training and coordinate assignments for time-sensitive activities across multiple teams
• Author, review, and approve technical documents in GMP Quality systems, including data reports, SOPs, and Work Instructions
• Drive standardization of data, chromatographic overlays, and data verification activities globally
• Lead continuous improvement projects and manage deviations, CAPAs, and cross-functional investigations
• Collaborate with cross-functional teams across multiple sites and time zones to coordinate stability studies
• Participate in audits and inspections across multiple manufacturing and testing sites
• Mentor and train staff to ensure high-quality results and adherence to project timelines

Requirements

• Master's degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
• 10+ years of experience in Quality, Operations, or Scientific roles
• Proven expertise in managing teams and motivating staff within a digital GMP Quality environment
• Demonstrated proficiency in biologics manufacturing processes, analytical methods, and cGMP
• Expertise with chromatography systems and Laboratory Information Management Systems (LIMS)
• Strong scientific data management, organization, and critical thinking skills
• Proficiency in Microsoft Office Suite and virtual collaboration tools

Preferred Qualifications

• Experience working in a matrix environment across multiple time zones
• Expertise in computer applications such as Veeva, Spotfire, or SHINY
• Strong presentation and public speaking skills

About the Company

Amgen is a leading biotechnology company that harnesses the best of biology and technology to fight the world’s toughest diseases. Since 1980, Amgen has been a pioneer in the industry, discovering, developing, and manufacturing innovative medicines to help millions of patients improve their health outcomes.