14 days old

Process Development Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115253205
Amgen

Job ID: R-86202
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Amgen Thousand Oaks (ATO) facilities. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Process Development Engineer will apply cell culture and/ or purification process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing in a new innovative manufacturing suite using single use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic single-use manufacturing facility.

JOB RESPONSIBILITIES:

- 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 in manufacturing facilities

- Technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation

- Offer process validation support for late stage commercial processes

- Provide routine process monitoring and troubleshooting

- Data trending and statistical process analysis

- Support technical direction 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 Engineering or Operations experience

OR

Associate's degree and 6 years of Engineering or Operations experience

OR

High school diploma / GED and 8 years of Engineering or Operations experience

PREFERRED QUALIFICATIONS:
  • Master's Degree in Chemical or Biochemical Engineering
  • 3+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
  • Background in biologics tech transfer into commercial facilities
  • Upstream and/or downstream process knowledge:
    • Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes OR
    • Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
  • Strong capability of analysis, troubleshooting and problem solving
  • Ability to develop and follow detailed protocols
  • Independently motivated with ability to multi-task and work in teams
  • Excellent written and verbal communication skills with technical writing and presentation experience


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.

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.

PI115253205

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86202<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Process Development Engineer to join the Drug Substance Process Engineering team at our Amgen Thousand Oaks (ATO) facilities. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.<br><br>The Process Development Engineer will apply cell culture and/ or purification process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing in a new innovative manufacturing suite using single use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic single-use manufacturing facility.<br><br><b>JOB RESPONSIBILITIES</b>:<br><br>- Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites<br><br>- Perform commercial tech transfers of late stage Amgen products in manufacturing facilities<br><br>- Technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation<br><br>- Offer process validation support for late stage commercial processes<br><br>- Provide routine process monitoring and troubleshooting<br><br>- Data trending and statistical process analysis<br><br>- Support technical direction for process related deviations (NCs), CAPAs and change controls<br><br>- Identify and support process related operational excellence opportunities<br><br>- Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory<br><br><b>BASIC QUALIFICATIONS</b>:<br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of Engineering or Operations experience<br><br>OR<br><br>Associate's degree and 6 years of Engineering or Operations experience<br><br>OR<br><br>High school diploma / GED and 8 years of Engineering or Operations experience <br><br><b>PREFERRED</b> <b>QUALIFICATIONS</b>:<br><ul><li>Master's Degree in Chemical or Biochemical Engineering</li><li>3+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities</li><li>Background in biologics tech transfer into commercial facilities</li><li>Upstream and/or downstream process knowledge:<ul><li>Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes <b>OR</b></li><li>Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations</li></ul></li><li>Strong capability of analysis, troubleshooting and problem solving</li><li>Ability to develop and follow detailed protocols</li><li>Independently motivated with ability to multi-task and work in teams</li><li>Excellent written and verbal communication skills with technical writing and presentation experience</li></ul><br><br>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.<br><br>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.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/7eRWnmsYzN56sZ1NF7Y5y"> <p>PI115253205</p>

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Posted: 2019-11-07 Expires: 2019-12-08

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Process Development Engineer

Amgen
Thousand Oaks, CA 91360

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