Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer
Location
United States
Posted
82 days ago
Salary
0
No structured requirement data.
Job Description
Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer
3 Key Consulting
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Our ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops). - Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. - GMP or lab experience is a nice to have. - Strong problem solving and troubleshooting experience would be a plus. Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Cambridge, MA. site. Providing strong process engineering/technology transfer support of human therapeutic products in clinical development through commercial production. - The Engineer will apply process engineering knowledge in support of upstream and/or downstream technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. - Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer. Qualifications - Master’s degree OR - Bachelor’s degree and 2 years of Engineering or Operations experience OR - Associate’s degree and 7 years of Engineering or Operations experience OR - High school diploma / GED and 8 years of Engineering or Operations experience Requirements - At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops). - At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP). - Strong analytical capability, troubleshooting, and problem solving skills. Interview Process - Teams screening first - Panel interviews second
Job Requirements
- Master’s degree OR
- Bachelor’s degree and 2 years of Engineering or Operations experience OR
- Associate’s degree and 7 years of Engineering or Operations experience OR
- High school diploma / GED and 8 years of Engineering or Operations experience
- At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops).
- At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP).
- Strong analytical capability, troubleshooting, and problem solving skills.
- Interview Process
- Teams screening first
- Panel interviews second
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