Associate Director, Aseptic & Sterile Process Engineering

Role: Associate Director, Aseptic & Sterile Process Engineering, serves as a technical leader supporting advanced automated cell therapy manufacturing platforms. Responsibilities include developing and sustaining aseptic processing strategies for regulatory approval and commercial production, leading aseptic process simulation (media fill) strategies, ensuring inspection readiness, and managing contamination control and microbial strategies. Collaborates with quality, regulatory, automation, and equipment teams to incorporate aseptic principles into system design, and supports regulatory inspections and lifecycle management. Requirements: Bachelor's in Engineering, Biotechnology, or related field; 8+ years in pharmaceutical or cell/gene therapy manufacturing with hands-on aseptic processing experience; expertise in contamination control, environmental monitoring, and media fills. Preferred: Advanced degree (Master’s or PhD), experience with automated or robotic manufacturing systems, and familiarity with sterile connectors and external vendor collaborations. High-value biopharma specifics: cell therapy focus, advanced automated manufacturing environment, regulatory inspection support, and expertise in aseptic techniques, media fills, and contamination control. Reporting to the Cell Therapy Automation Site Deployment team; work setup involves on-site presence with potential hybrid options. Travel details are not specified.