Process Development Engineer

Amgen is seeking a 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.

Job Responsibilities:

• 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
• 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 support 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
• Support technical projects that may include experiment, equipment, or process design
• Present process performance and project updates at team meetings
• Actively engage in regulatory inspections and author CMC sections for regulatory filings

Opportunities:

• 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
• Experience in upstream and downstream drug substance unit operations

Basic Qualifications:

• Master's degree in Engineering

OR

• Bachelor's degree and 2 years of Engineering experience

Preferred Qualifications:

• Degree in Chemical/Biochemical Engineering
• 3+ 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
• Upstream and/or downstream process knowledge:
• 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 OR
• Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
• 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!

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.