Principal Scientist, Drug Substance Process Development & Manufacturing

Job description

The Role: We are seeking a Principal Scientist, DS Process Development & Manufacturing, to join our growing Drug Substance group at Generate:Biomedicines. This role will support monoclonal antibody (mAb) drug substance development with a strong MS&T focus, bridging process development, scale-up, tech transfer, and GMP manufacturing execution. The position offers broad exposure across upstream and downstream operations, CDMO management, and quality systems. Here's how you will contribute: - Support Drug Substance process development and manufacturing activities (e.g., upstream expression, purification, UF/DF, viral clearance) - Design and execute scale-up, process characterization, and PPQ-enabling studies - Own tech transfer and support GMP campaigns at CDMO (person-in-plant support as needed) - Review and/or author GMP documentation including batch records, change controls, deviations and CAPAs - Provide technical leadership for GMP manufacturing, including troubleshooting and data-driven decision making - Partner cross-functionally across CMC, QA, Regulatory, and Supply Chain to drive program execution - Drive continuous process improvement and process robustness initiatives - Le...