Our Gene Therapy client in Cambridge is looking to add a Toxicology Scientist to their team! This scientist will leverage their experience in hematology/immunology, cell and molecular biology to support the toxicology evaluation of genetically modified cell therapy products for immuno-oncology and rare diseases indications. Will be responsible for the design, development and execution of toxicology studies and contribute to defining the toxicology strategies for new therapies. This is a unique opportunity to make an immediate impact, to learn and apply cutting edge science in an innovative, fast-paced environment! Responsibilities include but not limited to:
- Design, develop and execute in vivo and ex vivo toxicology studies.
- Manage external studies at CROs.
- Contribute to defining the toxicology strategies for cell therapy programs
- Collaborate with research, CMC, and clinical groups throughout product development.
- Review/monitoring of gene and cell therapy regulatory guidance and related publications.
- Generate technical documents, SOPs, study reports and other forms of documentation for IND-enabling activities and assay development.
- Ph.D. in hematology, immunology, cell/molecular biology, or related discipline with 1+ years of industry or 2+ yrs of post-doc experience.
- Experience with traditional cell and molecular biology assay (ex. cell culture, flow cytometry, q/ddPCR, sequencing).
- Prior experience related to ex-vivo cell and gene therapy, gene editing or DNA repair biology.
- Prior experience with IPSc, immune or hematopoietic cells
- Strong written and communication skills; and an ability to collaborate effectively with a diverse team in a fast-pace and dynamic environment
- Experience relative to gene and cell therapy drug development, toxicology assessment and regulatory guidance
- Experience with cytogenetic and DNA-sequencing assays.