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Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Job Responsibility:
Serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio
Lead multi-functional NPI teams
Lead the NPI’s for necessary process, facility, equipment, materials, and training modifications
Development of project execution plans
Ensuring process requirements are effectively transferred into manufacturing
Coordination/execution of NPI activities
Function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management
Engage with network partners to develop process and technology strategies
Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes
Support generation, revision, review, execution, and approval of relevant technical documents
Ensure design/process transfer requirements are appropriately implemented
Support a safe working environment
Lead and manage change control processes for New Product Introductions (NPI)
Monitor and track NPI-related changes
Requirements:
Doctorate degree
Master’s degree and 2 years of Process Development, Engineering, or NPI experience
Bachelor’s degree and 4 years of Process Development, Engineering, or NPI experience
Associate’s degree and 8 years of Process Development, Engineering, or NPI experience
High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
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