Job Information
Amgen Engineer - Process Development in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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
Let’s do this. Let’s change the world. In this vital role you will be responsible for supporting process development and technical transfer of Amgen’s 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 Amgen’s 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
Associate’s degree and 4 years of Engineering or Operations experience
Bachelor’s degree and 2 years of Engineering or Operations experience
Master’s 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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