Lean transformation methodology and implementation in biopharmaceutical operations

Abstract

Amgen's Operations division is responsible for the production, release and distribution of commercial and clinical products. Due to industry consolidation, impending competition and revenue impacts, Amgen is facing the need to rapidly improve the Operations division and align different manufacturing sites. In order to achieve these goals, the Operations Improvement group is leading an initiative to bring about a lean transformation of Amgen's operations.This thesis analyzes the initial operational excellence efforts underway within Amgen Operations. The analysis includes an overview of the process by which the continuous improvement methodology and strategy were constructed, the creation of a training curriculum and the initial implementation of the continuous improvement methodology at specific manufacturing sites. In addition, the thesis explores the environment in which this program operates and the cultural and business drivers that support and detract from the efforts.The following conclusions were developed as a result of the analysis of the lean transformation efforts at Amgen. First, company and industry specific nomenclature is essential to make lean principles contextually relevant for the biopharmaceutical industry. Additionally, relevant metrics are needed to facilitate multi-site alignment and drive the desired behavior. Finally, continuous improvement efforts can effectively leverage a science-based culture by applying it to a new business context.