Director Process Development – Amgen – Thousand Oaks, CA, USA
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
The “business of parenteral delivery science” is crucial for Amgen’s success. The Parenteral Process Development group at Amgen provides technical leadership to Amgen’s biologics parenteral drug product and process design, commercialization and aseptic manufacturing science advancement.
Based in Thousand Oaks, the role of Director, Process Development will provide technical leadership for a team of scientists/engineers responsible for the technical aspects of Amgen’s drug product and process commercialization and manufacturing science advancement. This team will number approximately 25 people.
The Director, Process Development is expected to develop annual goals and strategic direction that drives advances in value, speed, efficiency and utility of data and commercialization information for Amgen. She/he will identify and drive value-added technical advances in aseptic processes, technologies and techniques, concepts, equipment and data generation to advance quality, efficiency and utility of the global commercialization process, the lifecycle of products, and the overall manufacturing strength of Amgen operations across the global networks. As the key contributor to Amgen’s commercialization process, the Director must maintain strong partnerships with all PD groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the commercialization lifecycle.
The Director, Process Development will interact with management and staff in PD and technical operations in other Amgen’s sites. The DPT organization has cultivated expertise in multiple functional areas, formulation, primary containers, packaging and labeling, equipment engineering and process design that must be integrated into global manufacturing strategies, processes and submission packages involving large-molecule proteins, small molecules, antibodies and other molecular entities. The growing global manufacturing network currently includes sites in Ireland, Puerto Rico, The Netherlands and the US.
Additional responsibilities include:
• Develop and maintain a high performance team of scientists and engineers with advanced degrees and experience in drug product process development.
• Drive continuous improvement in the drug product development process through technological innovation and alignment with regulatory and commercial manufacturing requirements.
• Guide group leaders and members of the Drug Product Commercialization Teams responsible for conducting process development on pipeline products during Commercialization as well as supporting commercial products in lifecycle management.
• Articulate and address the critical business and scientific trade-offs that must be made in specific process development and product lifecycle management efforts.
• Deliver progress reports and presentations and ensure that management is aware of the current status, progress and future needs within Operations.
• Fulfill talent management responsibilities for technical personnel including hiring, development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment.