Our growing Gene Therapy Client here in Cambridge is growing and looking to add an Associate Director to their Vector Technologies team! This will be a hands-on/SME lab role that will build out and manage a small team. Their mission is to pioneer controllable cell and gene therapies to deliver transformative outcomes for patients. Will drive the development of the engineered cell therapy products in the pipeline targeting cancer and advance product development by delivering critical capabilities in core technologies and key reagents. The Vector Technologies group is responsible for providing gene delivery production protocols and materials for the development of engineered cell therapies. The individual in this role will work collaboratively with the Analytical technologies, Cell technologies and Protein technologies groups to develop scalable and efficient viral vector production processes to support the Cell Therapy teams. Responsibilities include but not limited to:
- The ideal candidate would have expertise in in the development of processes for viral vector production to support engineered cell therapies. In addition, the candidate should have experience in managing teams and working with internal and external stakeholders in a highly matrixed fast paced environment.
- Identify and implement solutions to address current technical challenges in viral vector (i.e. lentivirus and retrovirus) research and early development production processes to support engineered cell therapies
- Serve as SME and support technology transfer as needed to viral vector CDMOs for cGMP clinical production
- Support immediate cell therapy needs for gene delivery while innovating to enable next generation gene delivery technologies
- Develop and/or improve methods in collaboration with research and analytical technologies to characterize viral vector production methods and primary cell transduction
- Lead supply of viral vector materials to support research studies, analytical development, and CDMO tech transfer activities
- Author and review technical and scientific documents including but not limited to ELN entries, study protocols and reports, SOPs and test methods
- Recruit talent as needed and manage Vector Technologies function with needed capabilities
- Define agenda and manage experimental activities in the Vector Technologies function and ensure proper documentation
- Degree (BS, MS, Ph.D. in a relevant discipline (i.e. chemical engineering, cellular and molecular biology, biotechnology)
- Minimum of 5-7 years relevant industrial experience with prior direct experience in viral vector biology and/or production
- Demonstrated track record with different gene delivery methodologies, such as lentivirus/ retrovirus/ AAV supporting early stage research and development of biologics
- SME in mammalian cell culture, including adherent and suspension cell culture scale-up/down and stable cell line development
- SME in viral vector production, including downstream purification and concentration methods (i.e. Tangential Flow Filtration)
- Familiar with product characterization methods relevant to viral vectors (e.g. cell line/ primary cell transduction, titering, flow cytometry, qPCR/ ddPCR, ELISA, MSD, and western blot)
- Experience managing laboratory scientists
- Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
- Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
- Experience in process development supporting early and/ or late stage development of biologics is highly desirable (cell therapy, gene therapy, vaccines, antibodies)
- Experience in primary cell gene delivery, including cell types such as T cells, TILs, NK cells
- Experience with DOE and application to process improvement
- Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy is a plus