3 Key Consulting, Inc. · 4 months ago
Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)
United States
Full-time
Remote
Entry, Mid Level
$36/hr - $41/hr
2+ years exp3 Key Consulting is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves providing process engineering and technology transfer support for drug substance manufacturing, focusing on upstream and downstream processes.
Professional ServicesCloud ComputingInformation TechnologyHuman ResourcesAdviceStaffing Agency
No H1B
Responsibilities
Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Assist in troubleshooting clinical and commercial runs
Execute data trending and statistical process analysis
Support technical direction for process-related deviations, CAPAs, and change controls
Identify and support process-related operational excellence opportunities
Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory
Qualification
Required
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
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
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
Preferred
Master's Degree in Chemical or Biochemical Engineering
1+ years of Process Engineering experience preferably related to upstream and/or downstream purification of commercial cGMP manufacturing facilities
Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
Biologics process knowledge: Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and equipment; scale-up factors, process deviations, quality attributes
Strong analytical capability, troubleshooting, and problem solving
Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid
Excellent written and verbal communication skills with technical writing and presentation experience
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
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