Engineer - Process Development

Engineer - Process Development What You Will Do

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, developing and optimizing 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%

• 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.

The Engineer professional we seek is an individual with these qualifications.

• 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

• 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

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. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• A comprehensive employee benefits package, including a Retirement and…