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

3 Key Consulting•Thousand Oaks, CA

1d•Remote

About The Position

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. This role is a supplement to the teams ongoing needs.

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.
Strong problem solving and troubleshooting experience would be a plus.
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
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