Senior Scientist / Principal Scientist, Analytical Development

Position SummaryThe Analytical Development Scientist will develop the analytical methods that release and characterize Oryon's autologous iPSC-derived dopaminergic neuron therapy. Reporting to the Chief Technical Officer, this individual will help build the analytical control strategy for the program.The method set covers starting material, intermediates, and drug product. It spans cell-based approaches, including flow cytometry, potency, and in-process controls, as well as molecular approaches, including quantitative detection of residual undifferentiated cells, genomic stability, and molecular identity. The team will work closely with Product Sciences, Process Development, and our academic collaborators. Level will be determined by experience.Key ResponsibilitiesDevelop, optimize, and qualify release, in-process, and stability methods across identity, purity, potency, and safety attributesEstablish testing and acceptance criteria for patient starting material and process intermediatesTransfer analytical methods from academic collaborators into Oryon laboratoriesDevelop the potency assay through qualification, in collaboration with Product SciencesDesign in-process controls suited to a closed manufacturing process, where speed and operator execution are design requirementsEstablish reference materials, controls, and system suitability criteriaExecute method qualification and validation consistent with ICH and latest regulatory guidanceOwn the stability program, including the stability master plan and study executionConduct analytical risk and gap assessments and set method development priorities accordinglyLead method transfer to quality control and contract testing laboratories, and manage outsourced testingIdentify and evaluate emerging analytical technologies that can improve sensitivity, speed, or analytical performanceSupport authoring of protocols, technical reports, qualification and validation documents, and analytical content for regulatory submissionsAssist with laboratory build-out and support establishment of laboratory systems and workflowsQualificationsRequiredPhD in cell biology, immunology, neuroscience, molecular biology, biochemistry, or related field, or MS with commensurate experienceSenior Scientist: 6+ years (fewer with an advanced degree). Principal Scientist: 10+ years, including ownership of an analytical control strategy for a cell or gene therapy productHands-on analytical development experience for cell or gene therapy products, with depth in at least three of the following:Multi-color flow cytometry, including panel design, gating strategy, and qualificationCell-based or surrogate potency assaysQuantitative molecular methods (qPCR, ddPCR, NGS-based)Detection of residual rare cell populationsGenomic stability and integrity assessmentIn-process controls, intermediate testing, or starting material characterization for a cell therapy processImaging-based or high-content methodsBioinformatics for sequencing-based methodsMethod qualification, validation, and transfer under a quality systemStrong data analysis and technical writing skills, including statistical tools for method developmentPreferredStem cell / iPSC or neural cell product experienceExperience developing a potency assay through qualificationExperience with contract testing laboratories and QC groupsFamiliarity with automated sample preparation, LIMS, or analytical data systems