Engineer - Upstream/Downstream

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 uses 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!

Amgen is seeking an Engineer to join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities.

The role will support technology transfer and process validation for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space. The position can be located at either Amgen Thousand Oaks (CA) or Amgen Cambridge (MA) locations.

Responsibilities include:

• 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

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Process Development experience

OR

Associate's degree and 6 years of Process Development experience
Or

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

Preferred Qualifications:

• Master's degree in Chemical/Biochemical Engineering or related discipline
• 3 + years of Process Engineering experience 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 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 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
• Experience in leading projects of moderate complexity

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.

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.