Amgen Senior Engineer - Upstream in West Greenwich, Rhode Island
The Senior Engineer - Upstream role will immersed in all aspects of operations in a commercial bulk drug facility.
Cell culture process parameters; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, impact of process deviations to growth and quality attributes
Harvest and clarification processes
Media prep, responsible for assessing risk for vendor and supplier issues, single use and disposable systems
Analyze manufacturability; responsible to understand process capabilities and means to achieve yield optimizations and increased efficiencies
Execute on technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials.
Provide technical support and lead troubleshooting of clinical and commercial drug substance manufacturing.
Design and execute experimentation to support process scale up, performing technical review of data, and authoring and reviewing GMP documentation.
Expected to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.
Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Manage project resources and elevate relevant issues to project lead and line management
Build and maintain high-performing, cross-functional partnerships and to lead matrix teams to advance complex projects to completion
Doctorate degree OR
Master's degree and 3 years of Engineering experience OR
Bachelor's degree and 5 years of Engineering experience OR
Associate's degree and 10 years of Engineering experience OR
High school diploma / GED and 12 years of Engineering experience
6 years of experience in drug substance process development, characterization and commercial process support
Advanced understanding of regulatory and cGMP requirements
Knowledge of disk stack centrifugation, perfusion filters, depth filters
Knowledge of raw material components including their solubility and incompatibility
Excellent written and verbal communication
Demonstrated ability to work under minimal direction
Be able to multi-task and function in a dynamic environment
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.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.