At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.
We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases
Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.
About the position:
- Lead, design, and execute development of cell-based, immuno-assays for characterization of cell and gene therapy products, viral vector, and gene-editing components of CRISPR technology.
- Design and execute plans for method qualification per ICH and regulatory guidelines.
- Execute and support sample testing for process characterization.
- Supervise and manage a team for assay development and testing activities to support various CRISPR programs.
- Generate, manage, evaluate, and maintain critical data in a highly organized manner, providing statistical analysis and troubleshooting where appropriate.
- Interact with CMOs and other vendors, as required and support method transfer and validation activities.
- Cross-functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams.
- Provide expertise on multiple techniques to support trouble shooting, enhancing of existing assays, and implementation of new ideas and technologies.
- Support analytical sections of regulatory filings for US, Europe and ROW.
- MS/ Ph.D. in cell biology, immunology, molecular biology, or related sciences with 8+ (MS) or 4+ (Ph.D.) years of relevant experience is required.
- Expertise in aseptic tissue/cell culture, handling T-cell, or mammalian primary cells is required.
- Experience in developing immunoassays using techniques like flow cytometry, ELISA, MSD, etc. is a must.
- Strong background or prior experience of working with CAR-T or T-cell biology or gene-editing technology is required.
- Strong writing, reviewing, and presentation skills is required.
- Must have strong organization skills, and ability to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
- Previous experience of managing/mentoring associate scientists in a laboratory setting is required.
- Must be independently motivated, detail oriented with good problem-solving ability.
- Experience of working with and managing external vendors/ CROs is preferred.
- Experience with qualifying and validating assays and understanding of ICH/ FDA guidelines is strongly desirable.
- Understanding or experience of method transfer to a GMP testing lab will be a plus.
- Understanding of statistical tools, such as JMP, DoE, Prism etc. is a plus
- Knowledge or experience of manufacturing cell and/or gene therapy products from whole blood, apheresis, or bone marrow is a plus.