[Hiring] Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer @3 Key Consulting

Role Description

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.

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.

Job 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. Experience in technical report writing is 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory.
• Experience related to Process characterization for manufacturing of biologics is highly preferred, including technical support for authoring and review of process characterization reports.

Qualifications

• 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.

Preferred Qualifications

• 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.

Top Must Have Skills

• Cell culture experience.
• Purification/downstream experience.
• Process characterization experience.

Nice to Have

• Monoclonal antibodies or mAbs manufacturing or on-floor support.

Day to Day Responsibilities

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

Red Flags

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

Interview Process

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

We invite qualified candidates to send your resume to [email protected] . If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers . You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.