Manufacturing Specialist

Summary: Seeking a Manufacturing Technical Support / Deviations Specialist with experience in GMP biologics manufacturing, technical troubleshooting, deviations, CAPA, change controls, and process improvement. The role supports clinical and commercial manufacturing and works closely with Manufacturing, Quality, Process Development, QC, Engineering, and other cross-functional teams.

Roles & Responsibilities: Provide real-time technical support and advanced troubleshooting for GMP manufacturing processes. Support deviations, investigations, CAPA, and change controls, including root-cause analysis and impact assessment. Draft and revise SOPs, batch production records, reports, and other GMP documentation. Support process data analysis, trending, technical reports, and client presentations. Work cross-functionally on technology transfer, facility fit, process scaling, and process validation. Identify opportunities for process and equipment improvements, efficiency gains, and waste reduction. Support biologics manufacturing processes including upstream cell culture, downstream purification, chromatography, TFF, buffer preparation, and filtration. Troubleshoot manufacturing equipment, including single-use systems, bioreactors, chromatography systems, and filtration equipment. Apply GMP, quality risk management, FMEA, and other compliance practices. Work in a cleanroom/cGMP manufacturing environment and support late-phase/commercial manufacturing activities.