Director, Process Development

Role: Head of Process Development for biologics at Keros, overseeing upstream and downstream process technologies to support multiple biologics programs. Responsibilities: lead and mentor process scientists and engineers, design and optimize bioreactor processes from bench to pilot scale, coordinate cross-functional activities including quality, manufacturing, and analytical teams, and ensure seamless tech transfer and regulatory compliance. Requirements: Bachelor's in a scientific discipline with at least 10 years of relevant experience, including 5+ years in managerial roles; strong knowledge of cGMP, bioprocess scale-up, and process validation; expertise in biologics process development, especially for biologics in early to late-stage development. Preferred: experience authoring CMC sections, managing teams of five or more, and working within regulatory frameworks for IND filings. High-Value: biologics, process development, cGMP manufacturing, cross-functional leadership, process scale-up, IND/regulatory experience. WorkSetup: not specified, but likely in a laboratory or manufacturing environment with management responsibilities.