Scientist: Viral Vector Process Analytical Sciences

Scientist: Viral Vector Process Analytical Sciences Location : Bedford, MA Job Code: SAPS-0012-18 Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases. Join HMI's high performing team and contribute to the overall success of our novel gene therapy and gene editing approaches. HMI seeks an outstanding Scientist, Viral Vector Process Analytical Sciences, to develop and refine analytical methods to characterize AAV vector products. The candidate will have the opportunity to lead the development and optimization of multiple AAV-specific analytical methods, which will be applied to the characterization of research/development-grade vector and will subsequently define the characterization and release method panel for clinical manufacturing. We seek candidates with proven ability to work independently and collaboratively to achieve optimized project plans, with the ultimate goal to deliver products that transform the lives of patients. About the role: Define and drive the analytical method development strategy for AAV-specific characterization, including size-exclusion, affinity, ion-exchange and reversed phase chromatography, capillary and gel electrophoresis, particle size characterization, analytical ultracentrifugation (AUC), and/or mass spectrometry. Lead internal process analytical laboratory activities, implementing multiple analytical methods to characterize research and development grade vector products produced by multiple sources. Establish standardized laboratory procedures to ensure robustness and reproducibility of analytical methods applied to the characterization of viral vector products. Mentor others and lead laboratory activities to troubleshoot process and analytics with associate scientists in the lab. Serve as primary point of contact with external testing organizations and/or contract manufacturing organizations, and lead technology transfer of all developed methods. Champion the qualification of critical product release methods. Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, method transfer documents, and prepare scientific presentations as needed. Provide program management leadership to ensure that internal development activities are aligned with external manufacturing milestones and timelines. Drive characterization and product release strategy and ensure readiness for GMP manufacturing in an efficient manner, with diligence to maintain program timelines. YourMembership_RPM. Keywords: Analytical Scientist, Location: Bedford, MA - 01730
Homology Medicines
Full time
Bedford, Massachusetts 01730, US