Engineer, Process Engineer

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic drug substance 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. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes.

GMP experience is a plus.

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. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.

• 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. Experience is technical report writing an expectation.
• 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.
• Experience related to Process characterization for manufacturing of biologics highly preferred. This includes technical support for authoring and review of process characterization reports.

• Masters degree and 2 years of Engineering or Operations experience
• Bachelors degree and 4 years of Engineering or Operations experience
• Associates degree and 7 years of Engineering or Operations experience
• High school diploma / GED and 8 years of Engineering or Operations experience

• Masters 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.

Pay Rate Range: $30-36/hr depending on experience