New Product Introduction Lead

Senior Associate Manufacturing role leading new product introduction projects at Amgen's Thousand Oaks drug product manufacturing facility. Responsible for technology transfer planning, cross-functional project coordination, and ensuring timely clinical and commercial product launches across the manufacturing network.

Responsibilities

• Lead new product introduction project planning and execution with accountability for scope, schedule, and risk management
• Coordinate across manufacturing, process development, supply chain, quality, and facilities functions to meet NPI milestones
• Conduct root cause analyses and resolve cross-functional issues with timely escalation to management
• Manage change controls in Trackwise and NPI records in Veeva system per GMP procedures
• Conduct Gemba walks to identify process improvements and report on team metrics and operational deliverables

Requirements

• Master's degree in Engineering, Biology, Chemistry, or Life Science
• Or Bachelor's degree in relevant field plus 2 years biotechnology operations experience
• Or Associate's degree plus 4 years biotechnology operations experience
• Knowledge of drug product manufacturing processes and GMP regulatory compliance
• Project management experience and technical writing skills
• Experience in regulated environments and drug product formulation operations
• Demonstrated ability to manage cross-functional teams and drive decision-making