Sr Mgr Engineering

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Let’s do this. Let’s change the world. In this vital role you will provide scientific and technical leadership within the Process Development upstream group at Amgen’s Flex Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

• Lead a technical team focused on biologics technology transfer, process validation, and plant start-up support
• Lead site activities for process monitoring, optimization, complex investigation, and product life cycle management
• Ensure safety and compliance of process development activities
• Collaborate with other site-functions and network drug substance teams in delivering plant goals
• Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
• Assure manufacturing operations are aligned with the registered process
• Provide support for regulatory filing, inspection, and other CMC activities
• Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience OR
• Associate’s degree and 10 years of biologics process development or commercial-scale technical support experience OR
• Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR
• Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience
  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
• 5+ years of management experience
• Strong and in-depth expertise in cell culture processes
• Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
• Experience developing staff to reach their full potential
• Knowledgeable in regulatory filings and inspections
• Familiarity in operational aspects of commercial biopharma manufacturing
• Familiarity in statistical analysis,…