Senior Engineer - Drug Substance Process Engineering Team
Amgen is seeking a Senior Engineer - Drug Substance Process Engineering Team at our Cambridge, MA office. This Senior Engineer will report to the Director of Process Development.
As a Senior Engineer on the Drug Substance Process Engineering Team, the Incumbent will be responsible for the engineering and technical transfer of processes to produce drug substance in Contract Manufacturing Organizations. The Senior Engineer will work with a group of engineers and scientists, mentor cross-functionally and across sites and disciplines as you use engineering principles to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline. Additionally, the Senior Engineer will use his/her experience in the oversight and/or operations of plant production facilities, including equipment utilization optimization, scheduling and time efficiency. Domestic and international travel will vary up to 15%.
Master's degree and 3 years of Engineering and/or Operations experience
Bachelor's degree and 5 years of Engineering and/or Operations experience
Associate's degree and 10 years of Engineering and/or Operations experience
High School Diploma/GED and 12 years of Engineering and/or Operations experience
- Engineer with 5 years of experience in providing and driving engineering deliverables for pharmaceutical processes and product development
- 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
- Possess strong understanding of regulatory and cGMP requirements
- Experience related to upstream and/or downstream 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, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
- Able to apply engineering principles and advanced statistical analysis 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 (e.g. HSV Elisa, plaque titer assay, SDS-Page, Western Blot)
- Experience with Quality by Design applied to pharmaceutical development
- Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification
- Strong communication and presentation skills, excellence in team work, mature process fit proficiency, command of operations plant safety practices.
- Fluency in German and/or Italian is a plus
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.