Specialist, Training and Development

Role: Manufacturing Training Specialist responsible for designing, implementing, and maintaining the site Manufacturing Training Program in a cell therapy environment. Objectives include developing training solutions compliant with regulatory standards, training staff (including new hires and existing personnel), and ensuring proficiency in aseptic processing and GMP practices. Responsibilities encompass creating training plans, conducting classroom and on-the-job training, assessing competency, maintaining documentation, and collaborating with Quality and Operations to improve training effectiveness. The role may involve performing cleanroom processing duties as a Manufacturing Associate. Qualifications: B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related field, with 4-5+ years of experience in a clinical laboratory or blood/cell culture processing environment. Skills in designing and delivering GMP-compliant training, proficiency in Microsoft Office, strong organizational and communication skills, and aseptic qualification are required. Preferred: Experience developing SOPs and TRNs, familiarity with cell therapy manufacturing, and GMP/GDP compliance. High-Value: Focus on cell therapy manufacturing, GMP training, aseptic processing, and collaboration with Quality and Operations teams. Work setup: On-site at the NJ facility, with responsibilities involving training delivery, documentation, and cleanroom operations.