Senior Engineer - Drug Substance Process Engineering (Oakland)
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The successful candidate will apply process engineering knowledge to support development, scale-up, and technology transfer of clinical and commercial purification processes.
Roles and responsibilities
Provide on-the-floor technical support when required for successful scale-up or transfer of process technology
Use strong written and verbal communication skills in technical writing and presentations
Represent Process Development and interface with other functions such as Process Development, Manufacturing, Quality, Validation and Regulatory
Design and perform experiments in the lab/pilot-plant to resolve technical issues observed during scale-up to or manufacturing at large scale when required per project
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
Experience related to upstream (cell culture) / downstream (purification) process development/characterization, technology transfer, scale-up, and manufacturing of biologics (cGMP)
Experience working with contract manufacturers
Possess advanced understanding of regulatory and cGMP requirements
Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Able to manage project resources and elevate relevant issues to project lead and line management
Independently motivated but also work well in team environment
Excellent written and verbal communication
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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. Associated topics: bio, biology, biomaterials, biophysics, bioprocess, bioprocessing, biosynthetic, hereditary, metabolic, nutrition