A Bachelors Degree with 10 years of relevant experience in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field OR a Masters degree with 10 years of relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field OR a PHD with 5 years relevant experience in in cell biology, developmental biology, tissue engineering, biomaterials, biomedical engineering or related field. Contribute substantively to FDA and other regulatory submissions by authoring and reviewing technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting product development and clinical advancement.