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

3 Key Consulting • Thousand Oaks, CA

1d • Remote

About The Position

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. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. 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.

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
• Master’s degree OR Bachelor’s degree and 2 years of Engineering or Operations experience
• Associate’s degree and 7 years of Engineering or Operations experience OR High school diploma / GED and 8 years of Engineering or Operations experience

Nice To Haves

• GMP or lab experience is a nice to have.
• 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

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

What This Job Offers

• Career Level: Mid Level