Process Development Drug Product Senior Engineer

Career Category

Job Description

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.

Process Development Drug Product Senior Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will work as part of the global Process Development organization supporting manufacturing at various drug product contract manufacturing sites, globally. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production.

• Act as a drug product technical authority, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compaction and coating.
• Build excellent business relationships with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.
• Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues.
• Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production.
• Tackle issues with drug product processing technologies and equipment.
• Identify and implement operational opportunities for current and new processes.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to support key production breakthroughs and establish relationships.

International travel will be required to visit contract manufacturing partner sites.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. experienced professional we seek is a strong communicator and successful collaborator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of scientific, engineering and/or related experience
• Associate’s degree and 8 years of scientific, engineering and/or related experience OR
• Bachelor’s degree and 4 years of scientific, engineering and/or related experience OR
• Master’s degree and 2 years of scientific, engineering and/or related experience OR
• Doctorate degree

Preferred Qualifications:

• Masters or PhD in Science or Engineering
• 5+ years of experience in Process Characterization, Technical Transfer (to commercial drug product sites), and Process Validation of oral solid drug products.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, encapsulation, and coating processes.
• Knowledge of cGMP’s and other worldwide regulatory requirements.
• Pharmaceutical manufacturing experience in oral solid drug products.
• Project management skills including the ability to manage numerous projects and evaluate project resource requirements.
• Solid understanding of quality and regulatory systems, drug product manufacturing and process validation.
• Experience handling and building positive relationships with contract manufacturing organizations.
• Proven ability in providing leadership to multi-functional teams to advance sophisticated projects to completion.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excl