22 days old

Engineer

Amgen
Cambridge, MA 02138
  • Job Code
    116868594
Amgen

Job ID: R-90403
Location: Cambridge, MA, US 02139

This individual will join the Amgen Drug Product Global Manufacturing and Sciences group to provide technical support 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:

Process trending and performance evaluations

Technical writing for process evaluations, technical reports and technology transfer documentation

Ownership and review of technical protocols, reports, product impact assessments, and regulatory sections in support of marketing applications

Conduct process risk assessments, provide technology transfer and process scale-up support

Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.

Basic Qualifications:

Master's Degree

OR

Bachelor's Degree & 2 years of Engineering or Operations experience

OR

Associate's degree & 6 years of Engineering or Operations experience

OR

High school diploma/GED & 8 years of Engineering or Operations experience

Preferred Qualifications:

Master's Degree in Science or Chemical Engineering

Familiarity with clinical and commercial parenteral drug product manufacturing

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

Excellent written and verbal communication skills

Experience with technical writing of protocols and reports

Experience with DOE and analysis of data using software such as JMP

Strong organizational skills

Exposure to cGMP manufacturing and documentation

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.

PI116868594

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90403<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 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>Process trending and performance evaluations<br><br>Technical writing for process evaluations, technical reports and technology transfer documentation<br><br>Ownership and review of technical protocols, reports, product impact assessments, and regulatory sections in support of marketing applications<br><br>Conduct process risk assessments, provide technology transfer and process scale-up support<br><br>Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.<br><br><b>Basic Qualifications:</b><br><br>Master's Degree<br><br>OR<br><br>Bachelor's Degree & 2 years of Engineering or Operations experience<br><br>OR<br><br>Associate's degree & 6 years of Engineering or Operations experience<br><br>OR<br><br>High school diploma/GED & 8 years of Engineering or Operations experience<br><br><b>Preferred Qualifications:</b><br><br>Master's Degree in Science or Chemical Engineering<br><br>Familiarity with clinical and commercial parenteral drug product manufacturing<br><br>Skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes<br><br>Knowledge of protein biochemistry with regard to chemical and physical stability<br><br>Excellent written and verbal communication skills<br><br>Experience with technical writing of protocols and reports<br><br>Experience with DOE and analysis of data using software such as JMP<br><br>Strong organizational skills<br><br>Exposure to cGMP manufacturing and documentation<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/p7oJyWhDj8g6T2o5fdJ64"> <p>PI116868594</p>

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

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Engineer

Amgen
Cambridge, MA 02138

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