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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Principal Engineer Combination Product Operations – PFS & Lyo Kit Platform

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a product team in Combination Product Operations (CPO), work with cross-functional teams to support the development and commercialization of Amgen products around the globe. This role will lead a team through feasibility, development and commercialization of a unique to Amgen Self Administration Kit. Proven leadership and technical excellence, translating complex user needs and design requirements in an intuitive combination product, will be critical to achieve the essential enhanced patient experience for this unique product.

Responsibilities of this position may include:

• Leading a cross functional team to develop and commercialize a Self Administration Kit, to be launched globally
• Leading a high-functioning and high-performing team incl human factors engineering, device engineering, systems engineering, primary containers, labeling, risk management, secondary packaging, process engineering from start to finish
• Leading the financial planning and execution of the project
• Leading strategy/planning workshops to advance the project where needed
• Leading development and management of Integrated Project Plans (IPP) for all aspects of the project
• Leading development and management of internal program dashboard/communications.
• Partnership with Executive Directors of CPO and beyond to oversee, and challenge progress and key decisions.
• Lead the Hypercare / Post-launch management
• Developing and sharing best practices and tools

Win

What we expect of you

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

Basic Qualifications

• Doctorate degree and 2 years of Mechanical, Material Sciences or Chemical Engineering, Physics or similar experience in a Medical Combination Product field OR
• Master’s degree and 6 years of Mechanical, Material Sciences or Chemical Engineering, Physics or similar experience in a Medical Combination Product field OR
• Bachelor’s degree and 8 years of  Mechanical, Material Sciences or Chemical Engineering, Physics or similar experience in a Medical Combination Product field OR
• Associate’s degree and 10 years of Mechanical, Material Sciences or Chemical Engineering, Physics or similar experience in a Medical Combination Product field OR
• High school diploma / GED and 12 years of Mechanical, Material Sciences or Chemical Engineering, Physics or similar experience in a Medical Combination Product field

Preferred Qualifications

• Broad understanding of Combination Product design controls and Combination Product Regulatory requirements on a global scale
• Experience and knowledge of interdependencies of Combination Products, Drug Development, and Attribute Sciences
• Broad understanding of organizational structures and capabilities
• Deep understanding of Combination Product commercialization framework
• Program and Project Management skills including:

• Strategic planning, execution and prioritization - integrating people/processes to achieve high performance, with detailed tracking of progress. 
• Proactive risk assessment, management and mitigation
• Change management; ability to lead and thrive in ambiguous environment
• Consistent track record of success in operationalizing and executing critical initiatives
• Emotional Intelligence skills including:

• Executive presence across functions and different levels of leadership
• Influencing, understanding & addressing team dynamics
• Navigating within a matrix environment