Amgen Senior Process Engineer - Upstream in Thousand Oaks, California
Amgen is seeking a Senior Process Development Engineer to join the Drug Substance Technology Engineering team at our Amgen Thousand Oaks (ATO) facilities. We enable Amgen’s mission to serve patients by designing and implementing robust processes and innovative technologies using our scientific and engineering expertise for reliable and reproducible drug substance manufacturing. This is achieved through world class process engineering, technology transfer and manufacturing technical support of clinical and commercial human therapeutic products.
The role will support drug substance manufacturing activities at the Thousand Oaks site and will be primarily focused on a newly constructed, next generation manufacturing facility, utilizing cutting edge single use technology.
The successful candidate will play a key role in advancing a sizeable number of Amgen's pipeline biologics, including many of our innovative oncology molecules. They will partner with manufacturing, quality, analytical sciences, equipment engineering and process scientists to produce clinical supply and work toward commercial facility licensure.
Transfer, optimize and support cell culture and purification drug substance processes
Perform clinical and commercial tech transfers of late stage Amgen products from laboratories and across manufacturing facilities
Design and execute process validation studies for late stage commercial processes
Provide technical support for scale-up, transfer of process technology, and clinical and/or commercial manufacturing operation
Perform process monitoring, assess product impact, and provide technical troubleshooting using sophisticated digital tools
Perform data trending and statistical process analysis
Provide technical guidance and lead investigations for process related deviations, change control and operational excellence projects
Represent process development and collaborate with functions such as Manufacturing, Engineering, Quality, and Regulatory
Spearhead technical projects that may include experiment, equipment, or process design
Present process performance and project updates at team and management meetings
Actively engage in regulatory inspections and author CMC sections for regulatory filings
Join a highly technical team of scientists and engineers accelerating the Amgen pipeline
Work with multi-functional teams providing technical expertise related to process, validation, and commercial launch
Complete the start-up and support continuous improvement for a new and innovative single-use manufacturing drug substance facility
Execute technology transfer of multiple products intended for accelerated commercialization
Design and execute studies to support process and platform improvement
Participate in the process development commercialization business process for multiple programs and large molecule modalities
- Doctorate degree
- Master’s degree and 3 years of Process Engineering experience
- Bachelor’s degree and 5 years of Process Engineering experience
- Associates degree and 10 years Process Engineering experience
- High school diploma / GED and 12 years Process Engineering experience
Degree in Chemical/Biochemical Engineering
5+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of biologics (cGMP)
Demonstrated leadership skills and decision-making experience
Background in biologics tech transfer into commercial facilities
Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
Strong academic and applied experience in science and engineering, troubleshooting, and problem solving
Independently motivated with successful ability to multi-task and work in teams
Excellent written and verbal communication with experience with technical writing and presentations
Process development and optimization experience with late stage clinical or commercial products at production scale in a cGMP manufacturing facility.
Amgen is committed and dedicated 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. Come join us!
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.