Amgen is looking for a Manager Manufacturing that will lead a team of Manufacturing Specialists responsible for supporting Epogen® (EPO) Good Manufacturing Practices (GMP) commercial manufacturing at Thousand Oaks B7.
The Manager Manufacturing and team will be responsible for process ownership, change control, nonconformance investigations, CAPAs, project management, and GMP document ownership. The manager will be an active participant and role model in Lean culture and continuous improvement.
Responsible for staff selection, training, oversight, coaching, performance evaluations and development
Allocate, prioritize, monitor and report on B7 manufacturing change control records and nonconformance's
Collect data, report metrics, identify trends, evaluate risks and drive action on conditions or behaviors that could impact the quality and success of the manufacturing operations
Represent the manufacturing department at cross functional meetings and forums for quality systems management
Manage the manufacturing department's assessments and implementation of Operating Standard requirements, Global Operations Alerts and Global Safety Alerts
Develop manufacturing process owners who are accountable subject matter experts for all aspects of operations success in their area of ownership
Partner with engineering, process development and quality to perform robust root cause analyses of manufacturing events and determine appropriate scope for improvement CAPAs
Manage the change control and nonconformance process and systems for the manufacturing department
Develop and implement project management standards and controls for the manufacturing department
Develop effective project solicitation, prioritization and execution processes for the department
Master's degree and 3 years of Manufacturing, Quality or Engineering experience
Bachelor's degree and 5 years of Manufacturing, Quality or Engineering experience
Associate's degree and 10 years of Manufacturing, Quality or Engineering experience
High school diploma / GED and 12 years of Manufacturing, Quality or Engineering experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
9+ years of related manufacturing, quality or engineering experience
3+ years of experience in an Operations Engineer, Specialist or Manager role
3+ years of experience leading nonconformance investigations
Solid understanding of Quality Systems used in commercial manufacturing
Technical writing ability, including formal root cause analysis
Project management and presentation skills
Experience with continuous improvement methodologies
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
A little about us:
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