Amgen Engineer- Upstream/Downstream in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Engineer - Upstream/Downstream, Drug Substance Technology
What you will do
Let’s do this. Let’s change the world. In this vital role you will join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities.
The Engineer will report to the Sr Engineer, Process Engineering, and will work onsite at Amgen's corporate headquarters in Thousand Oaks, California. The position may be located at Amgen Cambridge (MA) location as well. The successful candidate will apply process engineering knowledge in support of technology transfer, process validation for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space.
Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
Perform commercial tech transfers of late stage Amgen products between and within manufacturing facilities
Provide process validation support for late stage commercial processes
Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations
Provide routine process monitoring and troubleshooting
Perform data trending and statistical process analysis
Provide technical contributions for process related deviations (NCs), CAPAs and change controls
Identify and support process related operational excellence opportunities
Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The Engineering professional we seek is a collaborative team-player with these qualifications.
Master’s degree in Chemical/Biochemical Engineering or related subject area
3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
Experience in biologics tech transfer into commercial facilities
Experience working in/supporting a commercial cGMP manufacturing facility
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
A firm understanding of cell culture process and related equipment; scale-up from bench to commercial scale, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes
Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
Process development (PD) experience supporting cGMP manufacturing at large scale
Strong capability in scientific/engineering/laboratory analysis, troubleshooting and ability to apply sophisticated problem resolution abilities
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
Bachelor’s degree and 2 years of Process Development experience
Associate’s degree and 6 years of Process Development experience
High school diploma / GED and 8 years of Process Development experience
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.