Specialist, Training and Development

Role: Manufacturing Training Specialist responsible for developing and implementing the site Manufacturing Training Program to ensure regulatory compliance and operational proficiency. Responsibilities include designing training solutions, conducting classroom and on-the-job training, assessing trainee skills, maintaining documentation, and supporting aseptic manufacturing of cellular therapeutic products in GMP environments. The role involves collaboration with quality, supply chain, and other departments to improve training efficacy and process adherence. Qualifications: B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering with 4-5+ years of relevant experience in cell therapy, GMP, or clinical lab settings. Requires strong knowledge of cell therapy processes, GMP compliance, and skilled in training design, delivery, and documentation. Proficiency in Microsoft Office is necessary. High-value biopharma specifics: focus on cell therapy, aseptic processing, GMP regulations, and sterile manufacturing in a clinical or manufacturing context. The position may involve routine cleanroom duties and equipment maintenance. Work setup: on-site at Summit West, NJ, with potential for flexible or hybrid work based on role requirements. Travel is not explicitly specified.