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Role Description

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.

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.

• 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.

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 experience

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.

Interview Process

• Teams screening first
• Panel interviews second