Amgen Process Engineer - Upstream/Downstream in West Greenwich, Rhode Island
The Process Engineer will 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. Responsible for providing on the floor support during clinical and validation runs and compiling relevant process data. Provide technical support and assist in the troubleshooting of clinical and commercial drug substance manufacturing.
Responsible to apply fundamental scientific principles to Biopharmaceutical manufacturing processes (upstream cell culture and downstream purification) including:
Cell culture processes; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes. Harvest and clarification processes used for mammalian cell culture processes.
Chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations.
Will manage chemical engineering principles for the scale up of unit operations from bench scale to commercial scale. Responsible for analyzing manufacturability; understanding process capabilities and means to achieve yield optimizations and increased efficiencies.
Master's degree OR
Bachelor's degree and 2 years of Engineering or Process Development experience OR
Associate's degree and 6 years of Engineering or Process Development experience OR
High school diploma/GED & 8 years of Engineering or Process Development experience
2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Excellent written and verbal communication
Demonstrated ability to work under moderate direction.
Able to analyze and interpret data
Be a self-starter with the ability to take on several projects at one time
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.