22 days old

Sr Engineer

Amgen
Cambridge, MA 02138
  • Job Code
    116868575
  • Jobs Rated
    8th
Amgen

Job ID: R-90404
Location: Cambridge, MA, US 02139

This individual will join the Amgen Drug Product Global Manufacturing and Sciences group to provide technical support and leadership of drug product clinical and commercial manufacturing processes. The position will be responsible for characterization, monitoring, optimization, and troubleshooting of formulation, filling, and finishing processes for parenteral manufacturing with both internal and external manufacturing sites. The individual will work with a team of process engineers to advance the optimization of drug product unit operations such as formulation, filling, lyophilization, and visual inspection.

Responsibilities will include:

Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.

Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.

Troubleshoots issues with drug product processing technologies and equipment.

Develops and characterizes drug product processes and transfer technology to commercial drug product sites.

Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.

Identifies and implements operational opportunities for current and new sterile operations.

Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.

Travel to domestic and international contract manufacturing sites required

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Engineering and/or Operations experience

OR

Bachelor's Degree and 5 years of Engineering and/or Operations experience

OR

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

OR

High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications:

Master's degree in Science or Chemical Engineering

6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation

Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability

Project management skills including the ability to manage multiple projects and evaluate project resource requirements

Strong knowledge of Quality systems, Drug Product Manufacturing and Validation

Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion

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.

PI116868575

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90404<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>This individual will join the Amgen Drug Product Global Manufacturing and Sciences group to provide technical support and leadership of drug product clinical and commercial manufacturing processes. The position will be responsible for characterization, monitoring, optimization, and troubleshooting of formulation, filling, and finishing processes for parenteral manufacturing with both internal and external manufacturing sites. The individual will work with a team of process engineers to advance the optimization of drug product unit operations such as formulation, filling, lyophilization, and visual inspection.<br><br><b>Responsibilities will include:</b><br><br>Act as a drug product contract manufacturing technical expert and team leader to provide leadership and solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for protein parenteral products.<br><br>Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.<br><br>Troubleshoots issues with drug product processing technologies and equipment.<br><br>Develops and characterizes drug product processes and transfer technology to commercial drug product sites.<br><br>Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.<br><br>Identifies and implements operational opportunities for current and new sterile operations.<br><br>Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.<br><br>Travel to domestic and international contract manufacturing sites required<br><br><b>Basic Qualifications:</b><br><br>Doctorate Degree<br><br>OR<br><br>Master's Degree and 3 years of Engineering and/or Operations experience<br><br>OR<br><br>Bachelor's Degree and 5 years of Engineering and/or Operations experience<br><br>OR<br><br>Associate's degree and 10 years of Engineering and/or Operations experience<br><br>OR<br><br>High school diploma/GED and 12 years of Engineering and/or Operations experience<br><br><b>Preferred Qualifications:</b><br><br>Master's degree in Science or Chemical Engineering<br><br>6 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation<br><br>Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability<br><br>Project management skills including the ability to manage multiple projects and evaluate project resource requirements<br><br>Strong knowledge of Quality systems, Drug Product Manufacturing and Validation<br><br>Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion<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/LYgMApu1eoppUB74iq27g"> <p>PI116868575</p>

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Posted: 2020-01-06 Expires: 2020-02-06

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Sr Engineer

Amgen
Cambridge, MA 02138

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Software Engineer
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