Independently implement and perform in-vitro tritosome assay using high resolution mass spectrometry to support new chemistry SAR screening for DsiRNA conjugates. Prepare and manufacture lipid nanoparticles (LNP) formulations to support both in-house in vivo studies in various orthotopic and sub-cutaneous tumor models and external collaborations, including academic labs and National Cancer Laboratories. Perform routine analytical assays for characterizing LNP formulations in terms of particle size, zeta potential, and payload encapsulation. Independently explore, optimize, and develop LNP formulation process, including pump configuration for in-line mixing and formulation purification techniques such as ultracentrifugation, dialysis, and tangential flow filtration (TFF). Independently develop and optimize LNP analytical characterization assays using Reverse-phase/Ion-Exchange/Size-Exclusion Liquid chromatography (HPLC/UPLC) for siRNA quantification and UPLC-Charged Aerosol Detector (CAD) for quantitative lipid analysis. Plan and perform pilot short- and long-term formulation stability studies and identify degradation profiles. Perform routine mass spec data processing and visualization, as well as data summary and presentation. Contribute to development of bio-registration software for metabolism identification data processing. Plan and conduct pilot stability study of lead DsiRNA conjugate drug product. Support QC method evaluation for external CMOs for CMC purposes.
Must have MS in Pharmaceutical Sciences, Analytical Chemistry or related field and 3 years of experience of industry experience with pharmaceutical/medical science research conducting PK-PD studies in preclinical and/or clinical phase 1 studies in GLP environment. Experience must include performing the following: separation and quantitation of samples in biological matrices using HPLC (RP, NP, SEC, SAX); qualitative and quantitative analysis for DMPK projects including metabolite ID using mass spectrometry and LC-MS/MS; PK data statistical analysis using WinNonlin software; Analytical/bioanalytical method development and qualification/validation; real time PCR for detecting and quantitation of mRNA transcribed by DNa delivered with viral vectors; drug administration (OP, IV, PI) biological sample collection, dissection and preparation; Fluorescent Spectroscopy, Cytotoxicity Assay and capillary electrophoresis; and SDS-PAGE and ELISA. We will also accept a BS and 5 years of experience.