Sr. Engineer - Cambridge, MA | Biospace
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Sr. Engineer


Cambridge, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job Description

As a Sr. Engineer in the Drug Substance Process Engineering Team, you will be responsible for the engineering and technical transfer of processes to produce drug substance in Contract Manufacturing Organizations.  You will work with a group of engineers and scientists, mentor cross-functionally and across sites and disciplines as you use engineering principles to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.  Experience in the oversight and/or operations of plant production facilities, including equipment utilization optimization, scheduling and time efficiency is necessary to succeed in his role.  Current project centers on the tech transfer of a biological process between manufacturing plants across the network.


Basic Qualifications

  • Doctorate Degree OR
  • Master's degree & 3 years of Engineering or Operations experience OR
  • Bachelor's degree & 5 years of Engineering or Operations experience

Preferred Qualifications

  • Chemical engineer with 5+ years of relevant experience in providing and driving engineering deliverables for pharmaceutical processes and product development.
  • 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, especially viral production
  • Possess strong understanding of regulatory and cGMP requirements
  • Experience related to upstream and/or downstream 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 especially downstream unit operations including IEX, SEC, TFF, UFDF, and sterile filtration among others.
  • Able to apply engineering principles and advanced statistical analysis 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 (e.g. HSV Elisa, plaque titer assay, SDS-Page, Western Blot)
  • Experience with Quality by Design applied to pharmaceutical development.
  • Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification
  • Strong communication and presentation skills, excellence in team work, mature process fit proficiency, command of operations plant safety practices.
  • Domestic and International Travel required up to 25%
  • Fluency in German and/or Italian a plus