Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)

3 Key Consulting is hiring an Engineer, Upstream/Downstream Drug Substance Process Development for a consulting engagement with a leading global biopharmaceutical company. The role involves providing strong process engineering and technology transfer support for human therapeutic products in clinical development through commercial production.

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

Requirements:

• 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
• 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