Scientist - Downstream Process Development
Core
Lead downstream process development for gene therapy programs (AAV and LVV), designing studies and performing hands-on operations at small and large scales.
Role type
Scientist, downstream process development lead
Builds
Drug substance for pre-clinical and clinical-stage gene therapy assets
Domain
Biopharmaceuticals, gene therapy, viral vectors
Required skills
downstream process development, chromatography, depth filtration, tangential flow filtration, ultracentrifugation, impurity clearance, adventitious virus clearance, Design of Experiments (DoE), statistical analysis, technical report authoring, regulatory filing support
Preferred skills
viral gene therapy, AAV or LVV modalities, cGMP requirements
Technologies
chromatography, depth filtration, tangential flow filtration, ultracentrifugation
Responsibilities
Define and advance downstream development plans; independently design, execute, and interpret process development studies; perform hands-on process operations at small and large scale; analyze study results to inform development strategy; author technical reports for regulatory submissions; present technical recommendations to stakeholders; provide technical guidance to team members; coordinate laboratory activities and resources
Seniority
Mid-level, hands-on IC