Amgen Engineer - Upstream in Thousand Oaks, California
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 successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen's Thousand Oaks site.
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, Validation and Regulatory
Master's degree or Master's degree completed by June 2018
Bachelor's degree and 2 years of Engineering or Operations experience
Associate's degree and 6 years Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications :
*MS in Chemical/Biochemical Engineering and 3 years Process Engineering experience related to biochemical engineering, cell culture, and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
*Upstream process knowledge and hands on cell culture 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
*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 discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities-from training and education to expanding current job responsibilities.
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.