Engineer, Biologics Purification, Upstream​/Downstream​/Tech Transfer - Remote; JP

Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote

Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client 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.

• 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.

• Master's degree and 2 years of Engineering or Operations experience
• Bachelor's degree and 4 years of Engineering or Operations experience
• Associate's degree and 7 years of Engineering or Operations experience
• High school diploma / GED and 8 years of Engineering or Operations experience

• 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.

• Cell culture experience, Purification /downstream experience, process characterization experience
• Nice to have:
  Monoclonal antibodies or mAbs manufacturing or on floor support

Assist senior staff in technical writing, process tech transfer, data monitoring

No experience, not enough experience in biopharma or biotech, no experience in cell culture/upstream, purification/downstream or technical report writing

Teams interview. Screening 30 minute Microsoft team's interview with me. Second round
- Team's interview 30 minute each approximately with 3 other team members.