Amgen
biotech
Engineer-ProcessDevelopment
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Engineer - Process Development at Amgen. Skills: Process Development, Technology Transfer, Drug Substance Synthetics Processes, Chemical Engineering Fundamentals, Process Scale-up, Process Optimization, Process Characterization, Statistical Analysis/DoE. supporting process development and technology transfer of Amgen’s drug substance synthetics processes across all phases of development and commercialization. applying chemical engineering fundamentals to generate process understanding and implem”
What You'll Achieve.
implement scalable drug substance processes that deliver Amgen’s pipeline; make a lasting impact on the lives of patients; help people live longer, fuller happier lives
Industry & Context.
solve processing issues; evaluate opportunities for process improvements; troubleshooting operations; resolve complex problems; Suggest problem resolution; provide troubleshooting guidance; recommend process improvements
Domestic and International Travel: up to 20%
What They're Looking For.
Must Have
Master’s degree, Bachelor’s degree and 2 years of Engineering or Operations experience, Associate’s degree and 6 years of Engineering or Operations experience, High school diploma / GED and 8 years of Engineering or Operations experience
Nice to Have
Academic background in Chemical Engineering, 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic 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 utilizing first principal models (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, Working knowledge of standard plant operations and safety practices, Excellent project management skills, verbal communication and presentation skills
What You'll Do.
supporting process development and technology transfer of Amgen’s drug substance synthetics processes across all phases of development and commercialization
applying chemical engineering fundamentals to generate process understanding and implement scalable drug substance processes
partnering with a multi-functional group of engineers and scientists through the process development cycle
develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support
experimental design and execution
process risk analysis
process characterization
facility fit assessment
in-plant support of production operations during process execution and equipment commissioning
select and execute standard experimental
modeling and engineering techniques for process optimization
and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities
Initiate and complete technical tasks in lab
and manufacturing environments
Author documents for process understanding
and development/characterization
Function as a technical expert to equipment or systems regarding troubleshooting operations
Frequently become actively involved in daily production or development operations when required to meet schedules or to resolve complex problems
Routinely monitor manufacturing processes for performance indicators and operations
Suggest problem resolution
provide troubleshooting guidance and recommend process improvements
Apply engineering principles and statistical analysis
including design of experiments
in order to solve processing issues and evaluate opportunities for process improvements
Contribute to key regulatory and quality activities such as non-conformance
process performance qualification and continued process verification
How You'll Work.
Team & Collaboration
partner with a multi-functional group of engineers and scientists; Communicate and collaborate with Manufacturing, Process Development, and Quality departments
Communication Scope
verbal communication and presentation skills
Process & Methodology
Excellent project management skills
Full Job Description
## **Career Category** Engineering ## ## **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. 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. ## **Engineer - Process Development** ## ## **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 technology transfer of Amgen’s drug substance synthetics 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. The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Amgen develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process ch
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