The candidate will have a highly visible and integral role towards the process development, scale-up, and manufacturing of Gene Therapy LNPs. The ideal candidate will have experience with lipid nanoparticle formulation, various mixing equipment, TFF system, characterization tools and understanding/knowledge of process parameters. In this highly collaborative and cross functional role, you will help develop/optimize the client process and improve process understanding for multiple programs at various stages of non-clinical development.Job ResponsibilitiesSupport scale up development and optimization of LNP drug product formulation processes and storage form development for gene therapiesProvide formulation support for non-GLP large animal studies.Work with cross functional teams to support process transfer, scale-up, and resolving process trouble shootings.Formulate and characterize LNPs for preclinical studies internal and external to support consistency and high-quality readout across batches and stability evaluations.Maintain records of all relevant data in the electronic laboratory notebook system, hard cover recording (batch record) and present findings to client project teams.Contribute SOP, batch records, report, campaign summary reports, etcs.Other duties as assigned.
