Engineer - Drug Substance Technology & Engineering

Employer: Amgen
Location: Cambridge, MA, US
Start date: May 17, 2019

Discipline: Science/R&D, Pharmacology
Required Education: Masters Degree/MBA
Position Type: Full time
Hotbed: Genetown, Best Places to Work

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Job Details
Company

Job Details

As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment.

Domestic and International Travel: up to 15%

Basic Qualifications

Master's degree
OR
Bachelor's degree and 2 years of Engineering or Operations experience

OR
Associate's degree and 6 years of Engineering or Operations experience

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

Preferred Qualifications

Education background in Chemical Engineering, Bioengineering or Biotechnology
2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
Experience working with commercial manufacture of biologics using single use technology
Basic understanding cGMP requirements
Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Experience in the analysis of data generated from a variety of analytical techniques
Regulatory knowledge and interactions
Strong oral and verbal communication and presentation skills
Fluency in foreign languages

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info

Website: http://careers.amgen.com/
Phone: 805-447-1000
Location: Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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