Amgen Process Engineer - Cell Culture in Thousand Oaks, California

Amgen is seeking an Engineer at its main headquarters in Thousand Oaks, CA to join the Drug Substance Process Engineering team and will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen's Thousand Oaks site. THe Process Engineer will report to the Director Process Development.

Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. We provide process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

Key Activities for the Process Engineer include:

  • Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites

  • Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation

  • Provide routine process monitoring and troubleshooting

  • Perform data trending and statistical process analysis

  • Provide technical support for process related deviations (NCs), CAPAs and change controls

  • Identify and support process related operational excellence opportunities

  • Represent process development and interface with other functions such as Manufacturing, Quality, Validation and Regulatory

Basic Qualification

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

  • MS in Chemical/Biochemical Engineering and 3 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and commercial manufacturing of biologics (cGMP)

  • Upstream process knowledge and hands on cell culture pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance

  • A good understanding of cell culture process and associated equipment; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes. Good knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes

  • Process development experience in supporting cGMP manufacturing at large scale

  • Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills

  • Ability to develop and follow detailed protocols

  • Independently motivated with ability to multi-task and work in teams

  • Excellent written and verbal communication

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.

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.