Engineer - Biologics Drug Substance Processes
Amgen is seeking an Engineer - Biologics Drug Substance Processes to join our Drug Substance Technology & Engineering Team at our Cambridge, MA office. This Engineer will report to the Director of Process Development.
As an Engineer in the Drug Substance Technology & Engineering Team, the Incumbent 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. The Engineer will work with as member of a team of engineers and scientists, using engineering principles to implement manufacturing process in a cGMP environment. Domestic and international travel will vary up to 15%.
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
- 2 years of 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
- Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Experience in the analysis of data generated from a variety of analytical techniques
- Strong oral and verbal communication and presentation skills
- Fluency in foreign languages
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.