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Engineer- Drug Substance Process Engineering team- REMOTE (JP9495)

Cambridge, Massachusetts · Biotech/Pharmaceutical
Job Title:  Engineer- Drug Substance Process Engineering team- REMOTE (JP9595)
Location: Cambridge, Massachusetts 02138
Employment Type: Contract
Duration: 18 months with likely extensions
Job posting date: 11/24/2021
Note: Remote

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
The client is seeking an Engineer to join the Drug Substance Process Engineering team supporting the client Drug Substance Manufacturing facilities. We provide process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
  • The Engineer will report to a Sr Engineer.
  • The process engineering team is responsible for supporting multiple cGMP drug substance manufacturing facilities that utilize a broad spectrum of process equipment and technologies, including extensive application of single-use systems in our next generation production suites.
  • The successful candidate will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing of a range of large molecules, biologic modalities.

Qualifications:
  • Master’s degree
  • Bachelor’s degree and 2 years of Process Development experience
  • Associate’s degree and 5 years of Process

Top Must have Skill Sets:
  • Cell Culture and/or Purification engineering knowledge
  • Data trending
  • Good Manufacturing Practices

Day-To-Day Responsibilities:
  • Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites.
  • Perform commercial tech transfers of late stage the client products in manufacturing facilities.
  • Provide process validation support for late-stage commercial processes.
  • Provide routine process monitoring and troubleshooting.
  • Perform data trending and statistical process analysis.
  • Provide technical support for process related deviations (NCs), CAPAs and change controls.
  • Identify and support process related operational excellence opportunities.
  • Represent process development and interface with other functions such as Manufacturing, Quality, and Regulatory.

Employee Value Proposition:
The person in this role will work on different tech transfer projects.



Interview Process:
2 interviews by phone
 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.



 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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