Engineer - Upstream/Downstream
Amgen (NASDAQ:AMGN), 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.
Amgen is seeking an Engineer to join the Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. We provide process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
The Engineer will report to the Sr Engineer, Process Engineering, and will work onsite at Amgen's corporate headquarters in Thousand Oaks, California. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing.
Scope of work would include:
- Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
- Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Provide routine process monitoring and troubleshooting
- Perform data trending and statistical process analysis
- Provide technical support for process related deviations (NCs), CAPAs and change controls
- Identify and support process related operational excellence opportunities
- Represent process development and interface with other functions such as Manufacturing, Quality, and Regulatory
Bachelor's degree and 2 years of Process Development experience
Associate's degree and 6 years of Process Development experience
High school diploma / GED and 8 years of Process Development experience
- MS in Chemical/Biochemical Engineering and 3 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
- Experience working in/supporting a commercial cGMP manufacturing facility
- Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance
- A good understanding of cell culture process and associated equipment; 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. Good knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR A good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
- Process development experience in supporting cGMP manufacturing at large scale
- Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills
- Ability to develop and follow detailed protocols
- Independently motivated with ability to multi-task and work in teams
- Excellent written and verbal communication with experience with technical writing and presentations
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.