Senior, Cryopreservation Process Engineer CAR-T

Role: Senior Cryopreservation Process Engineer leading technical and operational aspects of cell processing and cryopreservation manufacturing within a GMP-regulated environment. Responsibilities: support development, scale-up, technology transfer, facility design, startup, qualification, and operational readiness; optimize processes for cell and gene therapies; develop and implement GMP support procedures; lead process validation, risk assessment, and change control strategies; oversee equipment qualification, manufacturing IT systems, and continuous improvement initiatives; act as a technical expert during inspections and troubleshooting; collaborate across functions to ensure scalable, compliant, and cost-effective manufacturing. Requirements: Bachelor's degree in Engineering, Bioscience, or related field; minimum 4 years’ experience in cGMP manufacturing, process development, validation, or quality management; strong understanding of aseptic processing, cell/gene therapy manufacturing, and GMP regulations. Preferred: experience in cell/gene therapy (CAR-T), equipment CQV, technology deployment, and continuous improvement methodologies like Lean or Six Sigma. HighValue: expertise in cell/gene therapy manufacturing, cryopreservation, GMP operations, validation, and automation systems. WorkSetup: based in Raritan, NJ, with an emphasis on cross-functional collaboration and operational excellence.