Director / Sr. Director, Process Development

Role: Lead process development and technical transfer for autologous cell therapy manufacturing, ensuring scalable, robust processes aligned with regulatory standards. Responsibilities: oversee process characterization, control strategy development, validation planning, and commercialization activities; drive continuous improvements; support regulatory submissions and manufacturing readiness; lead cross-functional teams across Manufacturing, Quality, Regulatory, and Analytical Development; manage and develop process scientists and engineers. Requirements: PhD, MS, or equivalent in Chemical/Biomedical Engineering, Biological Sciences, or related field; 10+ years in biopharma or cell therapy, with leadership experience; expertise in GMP biologics or cell therapy process development, validation, and regulatory compliance; strong knowledge of process characterization, validation, and control strategies; experience with late-stage development and commercialization support, preferred with autologous cell therapy. HighValue: autologous cell therapy, biologics, process development, process validation, regulatory submissions, GMP manufacturing, late-stage development, commercialization, cross-functional leadership, technical transfer. WorkSetup: not specified; likely hybrid or on-site depending on the organization.