10 days old

Process Development Product Engineer/Scientist

Amgen
Cambridge, MA 02138
  • Job Code
    116956916
Amgen

Job ID: R-90262
Location: Cambridge, MA, US 02139

Amgen is seeking a Process Development Product Engineer/ Scientist to work with our contract manufacturing organizations across the world and resolve challenges encountered in commercial production of oral solid drug products.

This role will be based out of Amgen Massachusetts, as part of the global Process Development organization and will support new product introductions, lifecycle changes and ongoing commercial production.

International travel to visit contract manufacturing partner sites.

Responsibilities:

  • Develop as a drug product technical expert, to provide leadership and solutions troubleshooting oral solid drug product manufacturing, for unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compression and coating.
  • Work with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.
  • Participate in cross site team meetings to support contract manufacturers and to identify and resolve potential issues.
  • Provide process development expertise for commercial drug product processing in specific areas such as process characterization, technology transfer, process validation and routine commercial production.
  • Troubleshoot issues with drug product processing technologies and equipment.
  • Identify and implement operational improvements for drug product commercial processes.
  • Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
  • Visit contract manufacturing sites to observe production operations and build relationships.


Basic Qualifications:

Master's degree
OR
Bachelor's degree and 2 years of pharmaceutical manufacturing experience
OR
Associate's degree and 6 years of pharmaceutical manufacturing experience
OR
High school diploma / GED and 8 years of pharmaceutical manufacturing experience

Preferred Qualifications:
  • Masters in a Science or Engineering or a related discipline.
  • 3+ years of experience in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, coating and encapsulation processes.
  • Experience managing contract manufacturing organizations (CMOs).
  • Project management experience.
  • Demonstrated ability to lead multiple projects and drive results.
  • Knowledge of pharmaceutical manufacturing processing in a GMP environment.
  • Proven problem-solving ability and collaboration.
  • Excellent oral and written communications skills.
  • Strong academic results in a bachelor's degreein Science, Engineering or a related discipline.


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.

PI116956916

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90262<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a Process Development Product Engineer/ Scientist to work with our contract manufacturing organizations across the world and resolve challenges encountered in commercial production of oral solid drug products.<br><br>This role will be based out of Amgen Massachusetts, as part of the global Process Development organization and will support new product introductions, lifecycle changes and ongoing commercial production.<br><br>International travel to visit contract manufacturing partner sites.<br><br>Responsibilities:<br><br><ul><li>Develop as a drug product technical expert, to provide leadership and solutions troubleshooting oral solid drug product manufacturing, for unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compression and coating.</li><li>Work with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.</li><li>Participate in cross site team meetings to support contract manufacturers and to identify and resolve potential issues.</li><li>Provide process development expertise for commercial drug product processing in specific areas such as process characterization, technology transfer, process validation and routine commercial production.</li><li>Troubleshoot issues with drug product processing technologies and equipment.</li><li>Identify and implement operational improvements for drug product commercial processes.</li><li>Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.</li><li>Visit contract manufacturing sites to observe production operations and build relationships.</li></ul><br><br>Basic Qualifications: <br><br>Master's degree<br>OR<br>Bachelor's degree and 2 years of pharmaceutical manufacturing experience<br>OR<br>Associate's degree and 6 years of pharmaceutical manufacturing experience<br>OR<br>High school diploma / GED and 8 years of pharmaceutical manufacturing experience<br><br>Preferred Qualifications: <br><ul><li>Masters in a Science or Engineering or a related discipline.</li><li>3+ years of experience in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, coating and encapsulation processes.</li><li>Experience managing contract manufacturing organizations (CMOs).</li><li>Project management experience.</li><li>Demonstrated ability to lead multiple projects and drive results.</li><li>Knowledge of pharmaceutical manufacturing processing in a GMP environment.</li><li>Proven problem-solving ability and collaboration.</li><li>Excellent oral and written communications skills.</li><li>Strong academic results in a bachelor's degreein Science, Engineering or a related discipline.</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/4eraJ8f2GJnAIo6zuWPd8"> <p>PI116956916</p>

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Posted: 2020-01-09 Expires: 2020-02-09

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Process Development Product Engineer/Scientist

Amgen
Cambridge, MA 02138

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