Amgen is seeking a Senior 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 Senior Engineer will report to the Principal Engineer 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 at Amgen’s Thousand Oaks site.
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.
Responsibilities of the Senior Engineer – Purification / Cell Culture include:
- Provides dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production
- Supports transfer processes and process improvements from the laboratory into the manufacturing facility and between manufacturing sites
- Provides on-the-floor technical support for successful scale-up, transfer of process technology, and for routine clinical and/or commercial production
- Leads data trending and advanced statistical process analysis
- Provides technical support for all process related deviations (NCs), CAPAs and change controls
- Provides technical support for new equipment, technology and capital projects in the facility
- Identifies and supports process related operational excellence opportunities
- Support Process Validation activities occurring at the site
- Presents process performance at team and management meetings
- Supports process modeling to guide process development activities
- Identifies process implementation issues and drive optimization; technical project management; support of regulatory filings and inspections
- Provides exceptional organizational, leadership, teamwork, and communication skills so as to work effectively in a dynamic and challenging environment with enthusiasm and a proactive, positive attitude
- MS in Chemical/Biochemical Engineer or other biological engineering discipline
- 8+ years Process Engineering experience related to biochemical engineering, and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
- Biologics manufacturing at a commercial facility and hands on cell culture and/or purification experience at the pilot/clinical/commercial scale regarding the manufacture of a drug substance
- In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virusinactivation and virus filtration operations
- In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolismprofiling, process deviation impact to growth and quality attributes, harvest/clarificationprocesses, 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 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.
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© 2018 Amgen Inc. All Rights Reserved.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.
Executive / senior industry position
Thousand Oaks , United States