Senior Engineer - Drug Substance Technologies and Engineering
Amgen is seeking a Senior Engineer - Drug Substance Technologies and Engineering Team at either our Cambridge, MA office or global headquarters in Thousand Oaks, CA. This Senior Engineer will report to the Director of Process Development.
As a Senior Engineer on the Drug Substance Technologies and Engineering Team, the Incumbent will be responsible for the engineering and technical transfer of synthetics processes to produce Amgen's drug substance in Contract Manufacturing Organizations (CMOs) across all phases of development and commercialization. Further, the Senior Engineer will be well versed in chemical engineering fundamentals, process development, regulatory requirements and scale up with the ability to apply their skills. 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 expertise in tech transfer, process development, modeling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules. Domestic and international travel will vary up to 20%.
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 related to process development, technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment including technical support for nonconformance investigations and other commercial support activities
- Ability to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer
- Possess strong understanding of regulatory and cGMP requirements
- Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of analytical techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, particle size determination, etc.
- Ability to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
- Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
- Experience in working closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide enhanced understanding and guidance for synthesis and unit operations
- Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification
- Experience with Quality by Design and Process Analytical Technologies, applied to pharmaceutical development
- 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 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.