Senior Engineer- Process Development/NPI

Amgen • New Albany, OH

63d • $119,195 - $147,867

About The Position

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.

Requirements

• Doctorate degree in a relevant field.
• 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.

Responsibilities

• Serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio.
• Lead multi-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Capital Projects, Process Development and other business groups.
• Develop project execution plans and ensure process requirements are effectively transferred into manufacturing.
• Coordinate and execute NPI activities, including document preparation or revision, change control management, and manufacturing process modifications.
• Engage with network partners to develop process and technology strategies that achieve clinical/commercial development schedules while minimizing transfer risks.
• 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 and aligned with current manufacturing strategies.
• Lead and manage change control processes for New Product Introductions (NPI).
• Monitor and track NPI-related changes to ensure proper risk assessment and alignment with project timelines.

Benefits

• Comprehensive employee benefits package including health and welfare plans.
• Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees