Sr Engineer - Upstream/Downstream
Amgen is seeking a Sr. 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.
This individual will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. Scope includes: transfer processes and 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 routine clinical and/or commercial production; lead data trending and advanced statistical process analysis; provide technical support for all process related deviations (NCs), CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility; identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site; presentation of process performance at team and management meetings; process modeling to guide process development activities, identify process implementation issues and drive optimization; technical project management; support of regulatory filings and inspections.
• Doctorate degree
• Master's degree and 3 years of Engineering or Operations related experience
• Bachelor's degree and 5 years of Engineering or Operations related experience
• MS in Chemical/Biochemical Engineer or other biological engineering discipline and 5 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
• 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.
• In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
• In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques.
• Process validation, process characterization and process monitoring experience
• Experience in supporting regulatory inspections
• Process development experience in supporting cGMP manufacturing at large scale
• Good written and verbal communication skills
• Experience in preparing regulatory filings and participation in regulatory inspections
• Process development and optimization experience with late stage or commercial products
• Process equipment design and evaluation expertise
• Experience with risk analysis methodologies
• Independently motivated with ability to multi-task and work in teams
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.
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.