Sr Mgr Engineering

About the role

Join Amgens 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Provide scientific and technical leadership within the Process Development upstream group at Amgens Flex Batch Biologics Manufacturing Facility.
• Collaborate 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.
• 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.

Requirements

• High school diploma/GED and 12 years of biologics process development or commercial-scale technical support experience OR
• Associates degree and 10 years of biologics process development or commercial-scale technical support experience OR
• Bachelors degree and 8 years of biologics process development or commercial-scale technical support experience OR
• Masters 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

Qualifications

• Basic Qualifications: Meet at least one of the above educational requirements and 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
• Knowledgeable in regulatory filings and inspections
• Familiarity in operational aspects of commercial biopharma manufacturing
• Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing