Manufacturing Lead Operator, Aseptic Process

Role: Manufacturing Lead Operator, Aseptic Process, supporting CAR-T cell therapy production in a cGMP environment. Responsibilities: oversee aseptic manufacturing of personalized cell therapy, perform process unit operations (cell culture, purification, aseptic processing, cryopreservation), support process development, and drive continuous improvement within ISO 5 and ISO 7 cleanrooms. Collaborate with technical support, engineering, quality, and cross-functional teams to ensure high-quality, safe, and compliant manufacturing. Requirements: bachelor's in life sciences, engineering, or related field; minimum of 2 years' cGMP biotech/biopharma experience, preferably in aseptic or cell therapy manufacturing; strong understanding of cell-based product processes, regulatory requirements, and GMP standards; physical ability to handle biological materials, lift 50 lbs, and work in sterile environments. Preferred: prior experience with CAR-T manufacturing, BSL-2 facilities, and AI literacy. High-value: cell therapy (CAR-T), process development, GMP operations, biologics manufacturing, sterile fill/finish. Collaboration: internal teams (Manufacturing, Engineering, Quality) in a cross-functional setting. Location: Raritan, NJ, with shift work and possible overtime. The role emphasizes technical expertise, process troubleshooting, and maintaining compliance in a fast-paced cell therapy production environment.