Engineer

Planet Group
Cambridge, MA

Pay range: 30-40/hr
*depending on experience

Ideal candidate: 3+ years of industry experience, comfortable presenting. Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops) Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a huge plus.

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 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.

The Engineer will apply 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:
Under guidance of senior staff, the Engineer will perform the following:
- Transfer purification 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 collaborates with other functions such as Manufacturing, Quality, and Regulatory
Posted 2025-08-22

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