Key Responsibilities:
· Design, execute, and analyze toxicology studies (e.g. biodistribution, hemolysis, toxicity, etc.) to assess the safety profile of cell therapy products.
· Collaborate with cross-functional teams to ensure alignment between non-clinical safety and other areas of development, such as product design and manufacturing processes.
· Act as an expert in toxicology, providing guidance on study design, risk mitigation, and best practices in line with GLP standards and regulatory guidelines.
· Collaborate with and manage CROs to ensure high-quality, reproducible in vivo safety assessments.
· Generate and interpret data from in vivo studies, providing detailed reports and presentations to cross-functional teams and senior leadership.
· Support the preparation of regulatory submissions, including IIT and IND applications, by ensuring that preclinical safety data meets institutional and regulatory requirements.
· Stay updated on the latest advancements in toxicology, incorporating novel techniques and methods into safety testing where applicable.
· Ensure project timelines and deliverables are met, while continuously improving reliability.

Qualifications:
· Ph.D. in Toxicology, Pharmacology, Immunology, or a related field with 3+ years of experience in toxicology within the cell therapy, biotechnology, or pharmaceutical industry.
· Strong background in toxicology study design, extensive experience with in vivo models to assess the safety of biologics, cell therapies, or gene therapies.
· Experience in GLP-compliant toxicology study execution, including protocol development, study monitoring, and reporting for regulatory submission.
· In-depth knowledge of FDA and other regulatory agency guidelines related to preclinical safety testing and toxicology.
· Excellent data analysis and interpretation skills, with experience using software tools for statistical analysis and data visualization.
· Ability to communicate complex scientific data clearly and effectively to a wide range of audiences, including regulatory agencies and senior management.
· Strong project management and organizational skills, with the ability to manage multiple projects and timelines effectively.