Senior Associate, LCM Execution
Core
Planning, coordination, and execution of post-approval Lifecycle Management activities and Change Control implementation across Amgen's commercial portfolio.
Role type
Senior Associate, Lifecycle Management Execution
Builds
Compliant and high-quality execution of CMC variations, labeling updates, SKU rationalizations, and product discontinuations.
Domain
Pharmaceutical Supply Chain / Regulatory Affairs
Required skills
Post-approval Lifecycle Management processes, CMC variations, labeling changes, Change Control execution, GMP-regulated environments, Project management, Stakeholder management, Organizational leadership, Analytical capabilities, Problem-solving
Preferred skills
Product Lifecycle Teams (PLTs) experience, Pharmaceutical commercialization processes, SAP, Project portfolio management tools, Smartsheet/MS Project, Lean/Six Sigma, PMP/PRINCE2 certification
Technologies
SAP, Smartsheet, MS Project
Responsibilities
Oversee execution of post-approval Lifecycle Management activities; Ensure successful delivery of CMC variations and labeling changes; Translate Product Lifecycle Team decisions into executable work plans; Coordinate execution across Manufacturing, Quality, Regulatory Affairs, and Supply Chain; Monitor Change Control performance and compliance; Escalate critical risks and drive timely resolution.
Seniority
Senior, hands-on IC