Engineer - Drug Substance Technology & Engineering

Cambridge, MA, US
Jul 16, 2019
Required Education
High School or equivalent
Position Type
Full time
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. We have a presence in more than 75 countries worldwide and have reached millions of people in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses.

As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment. Ideally, we are seeking an Engineer who has full-time lab and industry experience. This role will work on process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale. The position will also apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements

Domestic and International Travel: up to 15%

Basic 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

Preferred Qualifications
  • Education background in Chemical Engineering, Bioengineering or Biotechnology
  • 2+ years of industry experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
  • 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
  • Basic understanding cGMP requirements
  • Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
  • Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
  • Experience in the analysis of data generated from a variety of analytical techniques
  • Regulatory knowledge and interactions

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status
  • Strong oral and verbal communication and presentation skills
  • Fluency in foreign languages