Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Job Posting Title

Engineer – Drug Substance Process Engineering

Location (City)

Cambridge, MA based team but flexible or remote work is an option

Job Description

The successful candidate will apply process engineering knowledge to support development, scale-up and technology transfer of clinical and commercial purification processes.

Roles and responsibilities

• Provide on-the-floor technical support when required for successful scale-up or transfer of process technology

• Apply strong written and verbal communication skills in technical writing and presentations

• Represent process development and collaborate with other functions such as Process Development, Manufacturing, Quality, Validation and Regulatory

• Design and perform experiments in the lab/pilot-plant to resolve technical issues observed during scale-up to or manufacturing at large scale when required per project

Basic Qualifications for Engineer

• 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

• Doctorate Degree

• Experience related to upstream (cell culture) / downstream (purification) process development/characterization, technology transfer, scale-up and manufacturing of biologics (cGMP) This includes technical support for nonconformance investigations and other clinical/commercial support activities

• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale

• Experience working with commercial manufacture of biologics using single use technology

• Experience facilitating with contract manufacturers

• Possess exceptional understanding of regulatory and cGMP requirements

• Able to apply engineering principles and statistical analysis, including design of experiments, in-order to tackle processing issues and evaluate opportunities for process improvements

• Experience in the analysis of data generated from a variety of analytical techniques

• Able to manage project resources and elevate relevant issues to project lead and line management

• Independently motivated but also work well in team environment

• Excellent written and verbal communication