19 days old

Senior Engineer - Upstream\/Downstream

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    124761259
Amgen

Job ID: R-105753
Location: Thousand Oaks, CA, US

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 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!

Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team responsible for supporting Amgen Drug Substance Manufacturing facilities.

The Sr. Engineer will play a key role in process engineering, process validation and technology transfer support for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space.

The position can be at either the Amgen Thousand Oaks (CA) or Amgen Cambridge (MA) locations.

Responsibilities for the Senior Engineer will include the following:

  • Transfer processes and process improvements from the laboratory into cGMP manufacturing facilities and between manufacturing sites
  • Provide on-the-floor and remote technical support to ensure the success of production runs
  • Perform process modeling/simulation and introduce new process technology for clinical and commercial production; perform process monitoring, data trending and advanced statistical process analysis activities; assess product impact, and provide technical troubleshooting using sophisticated digital tools
  • Provide technical support for process related deviations (NCs), CAPAs and change controls
  • Develop Process Validation strategies to support the commercialization of late-phase clinical programs and modifications to commercial processes
  • Present on process performance to management and technical forums
  • Identify and advance operational excellence opportunities to continually improve efficiency
  • Technical project management
  • Support of regulatory filings and inspections


Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of experience in Engineering or Operations

Or

Bachelor's degree and 5 years of experience in Engineering or Operations

Or

Associate's degree and 10 years of experience in Engineering or Operations

Or

High school diploma / GED and 12 years of experience in Engineering or Operations

Preferred Qualifications:

  • MS in Chemical/Biochemical Engineer or other biological engineering field and 5+ years Process Engineering experience 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.
  • In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
  • Solid understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques.
  • Process validation, process characterization and process monitoring experience
  • Experience in supporting regulatory inspections
  • Process development experience supporting and transferring technology for cGMP manufacturing at large scale
  • Good written and verbal communication skills
  • Experience in preparing regulatory filings and participation in regulatory inspections
  • Process development and optimization experience with late stage or commercial products
  • Process equipment design and evaluation expertise
  • Experience with risk analysis methodologies
  • Independently motivated with ability to multi-task and work in teams

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.



PI124761259
Posted: 2020-10-11 Expires: 2020-11-12

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Senior Engineer - Upstream\/Downstream

Amgen
Thousand Oaks, CA 91360

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