Principal Scientist, Commercial & Late-Stage Cell Culture Process Development

Role: Lead upstream process development for Denali's late-stage and commercial biologics, focusing on cell culture manufacturing for neurodegenerative disease therapies. Responsibilities: oversee process verification, investigations, deviations, and cross-site alignment; support lifecycle management activities including process improvements, tech transfer, change management, and regulatory filings; ensure technical consistency across manufacturing sites; design and interpret small-scale studies to inform scale-up and troubleshooting; maintain risk assessments and process history files; contribute to pipeline support and lifecycle standardization. Qualifications: PhD in Biology, Biochemistry, Chemical Engineering or related, with 10+ years' experience; expertise in commercial process support, technology transfer, cell culture characterization, process validation, and post-approval change management; proven ability to review batch records, support deviations, and work with regulatory bodies; broad knowledge in process characterization, DOE, analytics, and scale-up principles. Preferred: experience with CHO fed-batch processes, BLA authoring, and regulatory support. HighValue: biologics manufacturing, late-stage/commercial processes, process validation, regulatory interactions, cross-site collaboration. WorkSetup: not specified, likely hybrid or onsite based on industry norms.