21 days old

Senior Process Engineer - Upstream/Downstream

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119187781
Amgen

Job ID: R-95589
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior Process Development Engineer to join the Drug Substance Process Engineering team at our Amgen Thousand Oaks (ATO) facilities. Our mission is to translate processes under development to commercial reality for patients through scientific expertise and engineering innovation. We achieve this mission by providing process engineering and process validation support for human therapeutic products in clinical development all the way through commercial production.

The Senior 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. The support role will be primarily focused on a newly constructed, next generation manufacturing facility, utilizing innovative single use technology and focused on the advancement of Amgen's exciting oncology pipeline. In addition, they will partner with manufacturing, quality, and analytical and process scientists to support the start-up, validation and regulatory licensure of this dynamic single-use manufacturing facility.

Job Responsibilities:
  • Transfer cell culture/purification drug substance processes and process improvements from the laboratory into GMP manufacturing facilities and between manufacturing sites
  • Perform commercial tech transfers of late stage Amgen products in manufacturing facilities
  • Design and execute process validation studies for late stage commercial processes
  • Deliver technical support for flawless scale-up and transfer of manufacturing process technology, and during clinical or commercial manufacturing execution
  • Provide routine process monitoring and troubleshooting using advanced digital tools
  • Perform data trending and statistical process analysis
  • Provide technical guidance and lead investigations for process related deviations, CAPAs, and change controls
  • Identify and support operational excellence opportunities to improve the productivity and robustness of Amgen's manufacturing processes
  • Represent process development to plant management and collaborate with other functions such as Facilities Engineering, Quality, and Regulatory Compliance
  • Manage technical projects that may include experiment, equipment, or process design
  • Present process performance and project updates at team and management meetings
  • Support 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:
  • Master's Degree in Chemical/Biochemical Engineering
  • 3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of biologics (cGMP)
  • Background in biologics tech transfer into commercial facilities
  • Experience working in or supporting a commercial cGMP manufacturing facility
  • Upstream and/or downstream process knowledge
  • Knowledge of cell culture processes/ equipment; scale up, mass/oxygen transfer capabilities impact on metabolism, process deviations, raw materials and quality attributes OR
  • Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
  • Demonstrated strengths in scientific/engineering/laboratory 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 with experience with technical writing and presentations
  • Process development and optimization experience with late stage or commercial products
  • Experience with supervision or direct management of technical staff


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.

PI119187781

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95589<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior Process Development Engineer to join the Drug Substance Process Engineering team at our Amgen Thousand Oaks (ATO) facilities. Our mission is to translate processes under development to commercial reality for patients through scientific expertise and engineering innovation. We achieve this mission by providing process engineering and process validation support for human therapeutic products in clinical development all the way through commercial production.<br><br>The Senior 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. The support role will be primarily focused on a newly constructed, next generation manufacturing facility, utilizing innovative single use technology and focused on the advancement of Amgen's exciting oncology pipeline. In addition, they will partner with manufacturing, quality, and analytical and process scientists to support the start-up, validation and regulatory licensure of this dynamic single-use manufacturing facility.<br><br><b>Job Responsibilities:</b><br><ul><li>Transfer cell culture/purification drug substance processes and process improvements from the laboratory into GMP manufacturing facilities and between manufacturing sites</li><li>Perform commercial tech transfers of late stage Amgen products in manufacturing facilities</li><li>Design and execute process validation studies for late stage commercial processes</li><li>Deliver technical support for flawless scale-up and transfer of manufacturing process technology, and during clinical or commercial manufacturing execution</li><li>Provide routine process monitoring and troubleshooting using advanced digital tools</li><li>Perform data trending and statistical process analysis</li><li>Provide technical guidance and lead investigations for process related deviations, CAPAs, and change controls</li><li>Identify and support operational excellence opportunities to improve the productivity and robustness of Amgen's manufacturing processes</li><li>Represent process development to plant management and collaborate with other functions such as Facilities Engineering, Quality, and Regulatory Compliance</li><li>Manage technical projects that may include experiment, equipment, or process design</li><li>Present process performance and project updates at team and management meetings</li><li>Support regulatory filings and inspections</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of experience in Engineering or Operations<br><br>OR<br><br>Bachelor's degree and 5 years of experience in Engineering or Operations<br><br>OR<br><br>Associate's degree and 10 years of experience in Engineering or Operations<br><br>OR<br><br>High school diploma / GED and 12 years of experience in Engineering or Operations<br><br><b>Preferred Qualifications:</b><br><ul><li>Master's Degree in Chemical/Biochemical Engineering</li><li>3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and manufacturing of biologics (cGMP)</li><li>Background in biologics tech transfer into commercial facilities</li><li>Experience working in or supporting a commercial cGMP manufacturing facility</li><li>Upstream and/or downstream process knowledge</li><li>Knowledge of cell culture processes/ equipment; scale up, mass/oxygen transfer capabilities impact on metabolism, process deviations, raw materials and quality attributes OR</li><li>Knowledge of, harvest and purification processes knowledge / equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations</li><li>Demonstrated strengths in scientific/engineering/laboratory 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 with experience with technical writing and presentations</li><li>Process development and optimization experience with late stage or commercial products</li><li>Experience with supervision or direct management of technical staff</li></ul><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/LYmREOU17eoaSB74iq27g"> <p>PI119187781</p>

Categories

Posted: 2020-03-20 Expires: 2020-04-20

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Process Engineer - Upstream/Downstream

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast