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:
- Design, plan, advise, and monitor strategies for analytical development for all Immuno-oncology products.
- Lead, facilitate, and contribute to optimization of scientific/technical activities and processes within cell therapies development projects. Provide expertise for enhancing existing assays, and implementation of new ideas and technologies.
- Represent Analytics in the technical CMC project team.
- Advise/support in designing method qualification plans per ICH and regulatory guidelines.
- Participate in investigations, risk analyses and peer reviews; critically evaluate data, and review reports.
- Collaborate with internal and external partners, CMOs to lead or monitor outsourcing activities and ensure deliverables.
- Cross-functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams.
- Author technical reports, protocols, and analytical sections of regulatory filings for US, Europe and ROW.
- MS/ Ph.D. in cell biology, immunology, molecular biology, or related sciences with 12+ (MS) or 5+ (Ph.D.) years of relevant industry experience required.
- Minimum 2 years of relevant hands-on experience in Analytical development and CMC of biologics is strictly required. Prior experience of IND, BLA or equivalent regulatory filings preferred.
- Strong knowledge of T-cell biology, immunology, analytical methods for cell and gene therapy products is required.
- Experience with qualifying and validating assays and understanding of ICH/ FDA guidelines is highly desirable.
- Understanding of statistical tools, such as JMP, DoE, Prism etc. is desirable.
- Experience of working with and managing external vendors/ CROs is preferred.
- 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.
- Must be independently motivated, detail oriented with good problem-solving ability.
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.