Engineer - Process Development

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 characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.

Domestic and International Travel: up to 20%

The Engineer will be expected to:

* Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities.

* Initiate and complete technical tasks in lab, kilo/pilot plant, and manufacturing environments.

* Author documents for process understanding, transfer, risk assessment, facility fit, 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.

* Communicate and collaborate with Manufacturing, Process Development, and Quality departments.

* Contribute to key regulatory and quality activities such as non-conformance, process performance qualification and continued process verification.

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 an individual with these qualifications.

Basic Qualifications

Master's degree

Or

Bachelor's degree and 2 years of Engineering or Operations experience

Or

Associate's degree and 6 years of Engineering or Operations experience

Or

High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:

* 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

* Strong verbal communication and presentation skills

What you can expect of us

As we work to develop treatments that take care of others, we also work…