Tech Transfer - Remote (JP15407)

3 Key Consulting•Cambridge, MA

10d•Remote

About The Position

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team. This role will provide strong process engineering and technology transfer support for human therapeutic drug substance products, from clinical development through commercial production. The mission is to translate developmental processes into commercial reality through scientific expertise and engineering innovation. The Engineer will apply upstream and downstream process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. This role involves partnering with manufacturing, quality, analytical, and bench scientists to support a dynamic technology transfer environment.

Requirements

Master’s degree and 2 years of Engineering or Operations experience OR Bachelor’s degree and 4 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.
Experience related to Process characterization for manufacturing of biologics.
Technical report writing experience.
Cell culture experience.
Purification /downstream experience.
Process characterization experience.

Nice To Haves

GMP experience is a plus.
Experience related to Process characterization for manufacturing of biologics highly preferred.
Master’s Degree in Chemical or Biochemical Engineering.
2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities.
Background in biologics technology transfer into commercial facilities, new product introductions (NPIs).
Biologics purification process knowledge: Knowledge of upstream (cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill.)/ 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.
Experience in PC documentation, report reviews and technical writing preferred.
Monoclonal antibodies or mAbs manufacturing or on floor support.

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 collaborate with other functions such as Manufacturing, Quality, and Regulatory.
Assist senior staff in technical writing, process tech transfer, and data monitoring.