Principal Scientist, Commercial and Late-Stage Purification Process Development

Role: Lead downstream process development and technical support for commercial and late-stage biologics at Denali Therapeutics, focusing on process verification, investigations, and lifecycle management. Responsibilities: oversee downstream purification activities, ensure process consistency across sites, support process improvements, handle regulatory change management, and interpret process development studies to inform manufacturing. Qualifications: PhD in Biology, Biochemistry, Chemical Engineering, or related field; 10+ years of experience in bioprocessing, particularly in commercial downstream purification, process validation, and technology transfer; expertise with AKTA systems and antibody characterization; strong analytical, problem-solving, and cross-functional collaboration skills. Preferred: experience with BLA authoring and post-approval regulatory activities. High-Value: biologics, biologics process development, commercial manufacturing, process validation, lifecycle management, regulatory support, cross-site collaboration, late-stage process scale-up. Work setup and travel details are not specified.