Engineer - Process Development

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Engineer - Process Development

Live

What You Will Do

Lets do this. Lets change the world. In this vital role you will be responsible for supporting process development and technical transfer of Amgens synthetic drug substance manufacturing processes across all phases of development and commercialization. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgens pipeline of diverse synthetic and hybrid modalities.

The Engineer will partner with a multi-functional group of engineers and scientists to develop and optimize synthetic unit operations aligned with the intended phase of technology transfer and manufacturing. This work will include experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.

• In a team setting and with limited supervision, design and implement standard experimental, modeling and engineering techniques for process optimization, characterization, and scale-up of chemical processes in innovative facilities.
• Initiate and complete experimental techniques in the lab, kilogram-scale facility, and manufacturing environments.
• Author documents for process understanding, technical transfer, risk assessment, facility fit, and process development and characterization.
• Serve as a technical expert for lab equipment or systems.
• Be an active participant in daily production or development operations when required to meet schedules or to resolve sophisticated problems.
• Routinely monitor manufacturing processes for performance indicators and operations. Conceptualize resolutions to processing challenges, provide troubleshooting guidance and recommend process improvements.
• Apply engineering principles and statistical analysis, including design of experiments, to solve process issues and evaluate opportunities for process improvements.
• Communicate and collaborate with External Supply, Manufacturing, Process Development, and Quality departments.
• Contribute to key regulatory and quality activities such as non-conformances, process performance qualification, and continued process verification.
  
  
  

Win

What We Expect Of You

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

Basic Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience
• Associates degree and 4 years of Engineering or Operations experience
• Bachelors degree and 2 years of Engineering or Operations experience
• Masters degree
  
  
  

Preferred Qualifications

• Academic background in Chemical Engineering
• 2 years of experience in a Process Development or Process Engineering environment, with specific experience in the implementation and support of synthetic or hybrid manufacturing processes
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Basic understanding of cGMP requirements
• Experience building and applying first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Background in statistical analysis/DoE
• Solid understanding of standard plant operations and safety practices
• Project management skills
• Strong verbal communication and presentation skills
  
  
  

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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