Principal Engineer - Drug Substance Technology and Engineering
Amgen is seeking a Principal Engineer in our Drug Substance Technology and Engineering team, to be based in our Cambridge, MA office. The Principal Engineer will report to the Director of Process Development and will have managerial responsibilities.
The Principal Engineer 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. Working with a group of engineers and scientists, the Principal Engineer will lead teams across sites and disciplines using engineering principles to implement manufacturing process in a cGMP environment. Beyond the advancement of commercial and pipeline molecules, the Incumbent is expected to drive forward functional and cross-functional initiatives employing strategic approaches.
Doctorate degree and 2 years of Engineering and/or Operations experience
Master's degree and 6 years of Engineering and/or Operations experience
Bachelor's degree and 8 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
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- 8 years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes
- Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
- 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
- Strong understanding cGMP requirements
- Experience with regulatory filings and inspections
- Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including 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
- Deep understanding of operational aspects of biopharma and/or engineering industries
- 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 enabling strong relationships with internal and external stakeholders
- Ability to derive insightful strategies to improve business processes
- Experience in supervision of direct reports and mentoring of matrix-team members
- Fluency in one or more 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.