As part of the Drug Substance Technology and Engineering group within the Process Development organization, one of the primary responsibilities for the principal engineer position will be to provide leadership for introduction of new technologies into the global manufacturing network, using his/her process engineering and equipment design experience to assess risk and benefits of technologies and to ensure their robust performance. The Principal Engineer will lead and solve complex problems in a matrixed environment. The Principal Engineer will analyze available data, research technical subjects, and work with other subject matter experts to support rigorous technology evaluations.
In addition, this role will support the Amgen global network as a drug substance subject matter expert. The candidate will be expected to provide leadership on various workstreams related to troubleshooting existing technologies and improving technology robustness. The candidate may also support technical visits to evaluate external technology capabilities to and assess new technologies that could provide cost, throughput, or other benefits to Amgen manufacturing. This position can be located at either our Thousand Oaks, CA site or our Cambridge, MA site.
Doctorate degree and 2 years of Engineering or Operations experience
Master's degree and 6 years of Engineering or Operations experience
Bachelor's degree and 8 years of Engineering or Operations experience
Associate's degree and 10 years of Engineering or Operations experience
High school diploma / GED and 12 years of Engineering or Operations experience
- Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
- 8 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
- 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). 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
- 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
- Ability to prioritize efforts and delegates resources.
- 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