Engineer - Upstream/Downstream


Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

What you will do

Lets do this. Lets change the world. In this dynamic role you will join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. Responsibilities include:

  • Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites

  • 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 unique contributions to serve patients. The Engineer professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:
  • Masters degree OR

  • Bachelors degree and 2 years of Process Development experience OR

  • Associates degree and 6 years of Process Development experience OR

  • High school diploma / GED and 8 years of Process Development experience

Preferred Qualifications:
  • Masters 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)

  • 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

  • Experience working in/supporting a commercial cGMP manufacturing facility

  • A firm understanding of purification process and related equipment; scale-up from bench to commercial scale, chromatography, viral inactivation, viral filtration, ultrafiltraiton and diafiltration, and impact of process deviations to yield 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

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 improve 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Ready to Apply for the Job?

We highly recommend using Workday's robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the Upload My Experience functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile.

Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must advise their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being handled on a performance improvement plan (PIP) or other locally used formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our Internal Transfer Guidelines for more detailed information

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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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.