27 days old

Senior Engineer, Drug Substance Technologies and Engineering

Amgen
Cambridge, MA 02138
  • Job Code
    115601116
Amgen

Job ID: R-87846
Location: Cambridge, MA, US 02139
Additional Location: US - California - Thousand Oaks

Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? Amgen is seeking a Senior Engineer in the Drug Substance Technologies and Engineering team to be responsible for leading the technical transfer of Amgen's drug substance synthetics processes at Contract Manufacturing Organizations (CMOs) across all phases of development and commercialization.

The Sr. Engineer works with a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for its intended phase of technology transfer: process introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, and where necessary work with the sites(s) to introduce new equipment. Also utilizes their experience to provide in-plant support during key production activities.

The Sr. Engineer will be responsible to author technical reports and regulatory documents through the different phases of tech transfer and commercialization. And will represent Drug Substance Technologies as the process owner for all technical, manufacturing, life cycle and regulatory aspects of the commercial API within Amgen's Product Delivery Team.

Position to be located in either Cambridge, MA or Thousand Oaks, CA.

Domestic and International Travel: up to 20%

Responsibilities include but are not limited to:
  • Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
  • Represent organization within a multi-functional team to ensure deliverables aligned with tech transfer timeline are established and achieved.
  • Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
  • Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
  • Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
  • Author, review and/or approve of process documentation needed for process validation and commercialization.
  • Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.
  • Provide on the floor support to ensure successful scale up and rapid problem solving and decision making.
  • Lead or represent department as subject matter expert (SME) for process risk analysis.
  • Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.


Basic Qualifications

Doctorate Degree

Or

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

Or

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

Or

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

Or

High School Diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications
  • 5+ years of engineering experience driving deliverables for pharmaceutical processes development and manufacturing
  • Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities.
  • Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
  • Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
  • Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
  • Experience using data science and/or advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
  • Possess strong understanding of regulatory and cGMP requirements
  • Command of plant operations and safety practices
  • Strong communication and presentation skills
  • Fluency in German and/or Italian a plus


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.

PI115601116

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87846<br/><b>Location: </b>Cambridge, MA, US 02139<br/><b>Additional Location: </b>US - California - Thousand Oaks<br/><br/>Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? Amgen is seeking a Senior Engineer in the Drug Substance Technologies and Engineering team to be responsible for leading the technical transfer of Amgen's drug substance synthetics processes at Contract Manufacturing Organizations (CMOs) across all phases of development and commercialization.<br><br>The Sr. Engineer works with a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for its intended phase of technology transfer: process introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, and where necessary work with the sites(s) to introduce new equipment. Also utilizes their experience to provide in-plant support during key production activities.<br><br>The Sr. Engineer will be responsible to author technical reports and regulatory documents through the different phases of tech transfer and commercialization. And will represent Drug Substance Technologies as the process owner for all technical, manufacturing, life cycle and regulatory aspects of the commercial API within Amgen's Product Delivery Team.<br><br>Position to be located in either Cambridge, MA or Thousand Oaks, CA.<br><br>Domestic and International Travel: up to 20%<br><br><b>Responsibilities include but are not limited to:</b><br><ul><li>Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.</li><li>Represent organization within a multi-functional team to ensure deliverables aligned with tech transfer timeline are established and achieved.</li><li>Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.</li><li>Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.</li><li>Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.</li><li>Author, review and/or approve of process documentation needed for process validation and commercialization.</li><li>Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.</li><li>Provide on the floor support to ensure successful scale up and rapid problem solving and decision making.</li><li>Lead or represent department as subject matter expert (SME) for process risk analysis.</li><li>Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.</li></ul><br><br><b>Basic Qualifications</b><br><br>Doctorate Degree<br><br>Or<br><br>Master's degree and 3 years of Engineering or Operations experience<br><br>Or<br><br>Bachelor's degree and 5 years of Engineering or Operations experience<br><br>Or<br><br>Associate's degree and 10 years of Engineering or Operations experience<br><br>Or<br><br>High School Diploma/GED and 12 years of Engineering or Operations experience<br><br><b>Preferred Qualifications</b><br><ul><li>5+ years of engineering experience driving deliverables for pharmaceutical processes development and manufacturing</li><li>Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities.</li><li>Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.</li><li>Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms</li><li>Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.</li><li>Experience using data science and/or advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements</li><li>Possess strong understanding of regulatory and cGMP requirements</li><li>Command of plant operations and safety practices</li><li>Strong communication and presentation skills</li><li>Fluency in German and/or Italian a plus</li></ul><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/6e5wa5szODRGI8lwCoqNG"> <p>PI115601116</p>

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Posted: 2019-11-19 Expires: 2019-12-20

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Senior Engineer, Drug Substance Technologies and Engineering

Amgen
Cambridge, MA 02138

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