28 days old

Senior Engineer - Upstream/Downstream

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117289443
Amgen

Job ID: R-91720
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The team provides process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. The Sr. Engineer will report to the Principal Engineer of Drug Substance Manufacturing.

Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at ATO site. The Senior Engineer will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production.

Primary Responsibilities for the Senior Engineer will include the following:

  • Transfer processes and 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 routine clinical and/or commercial production; lead data trending and advanced statistical process analysis
  • Provide technical support for all process related deviations (NCs), CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility
  • Identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site
  • Presentation of process performance at team and management meetings; process modeling to guide process development activities, identify process implementation issues and drive optimization
  • Technical project management
  • Support of regulatory filings and inspections


Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience

Preferred Qualifications:

•MS in Chemical/Biochemical Engineer or other biological engineering discipline and 3+ 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

•In-depth 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 in supporting 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 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.

PI117289443

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91720<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The team provides process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. The Sr. Engineer will report to the Principal Engineer of Drug Substance Manufacturing.<br><br>Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at ATO site. The Senior Engineer will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production.<br><br>Primary Responsibilities for the Senior Engineer will include the following:<br><br><ul><li>Transfer processes and process improvements from the laboratory into the manufacturing facility and between manufacturing sites</li><li>Provide on-the-floor technical support for successful scale-up</li><li>Transfer of process technology, and for routine clinical and/or commercial production; lead data trending and advanced statistical process analysis</li><li>Provide technical support for all process related deviations (NCs), CAPAs and change controls; provide technical support for new equipment, technology and capital projects in the facility</li><li>Identify and support process related operational excellence opportunities; manage Process Validation activities occurring at the site</li><li>Presentation of process performance at team and management meetings; process modeling to guide process development activities, identify process implementation issues and drive optimization</li><li>Technical project management</li><li>Support of regulatory filings and inspections</li></ul><br><br><b><b>Basic Qualifications:</b></b><br><br>Doctorate degree<br>OR<br>Master's degree and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience<br>OR<br>Bachelor's degree and 5 years of [Job Code's Discipline and/or Sub-Discipline] experience<br>OR<br>Associate's degree and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience<br>OR<br>High school diploma / GED and 12 years of [Job Code's Discipline and/or Sub-Discipline] experience<br><br><b><b>Preferred Qualifications</b></b>:<br><br>MS in Chemical/Biochemical Engineer or other biological engineering discipline and 3+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)<br><br>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.<br><br>In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations<br><br>In-depth 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.<br><br>Process validation, process characterization and process monitoring experience<br><br>Experience in supporting regulatory inspections<br><br>Process development experience in supporting cGMP manufacturing at large scale<br><br>Good written and verbal communication skills<br><br>Experience in preparing regulatory filings and participation in regulatory inspections<br><br>Process development and optimization experience with late stage or commercial products<br><br>Process equipment design and evaluation expertise<br><br>Experience with risk analysis methodologies<br><br>Independently motivated with ability to multi-task and work in teams<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/JByajqcKBkzMUPJVfXzVe"> <p>PI117289443</p>

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Posted: 2020-01-21 Expires: 2020-02-21

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Senior Engineer - Upstream/Downstream

Amgen
Thousand Oaks, CA 91360

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