Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE3 Key Consulting is hiring an Engineer, Upstream/Downstream Drug Substance Process Development for a consulting engagement with our direct client, a leading global biopharmaceutical company.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.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.Why is the Position Open?Supplement to the teams ongoing needs.Top Must Have Skills: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 skillsDay to Day Responsibilities:Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilitiesProvide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operationAssist in troubleshooting clinical and commercial runsExecute data trending and statistical process analysisSupport technical direction for process-related deviations, CAPAs, and change controlsIdentify and support process-related operational excellence opportunitiesRepresent process development and collaborates with other functions such as Manufacturing, Quality, and RegulatoryBasic 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 experiencePreferred Qualifications:Master's Degree in Chemical or Biochemical Engineering1+ years of Process Engineering experience preferably related to upstream and/or downstream purification of commercial cGMP manufacturing facilitiesBackground 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 attributesStrong analytical capability, troubleshooting, and problem solvingIndependently 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 experienceRed Flags:Too much experience (15+ years)Many job changes within a year or lessInterview process:1. Teams screening first2. Panel interviews second