Scientist I, Bioanalytical Development

This is what you will do:The Scientist I will spend approximately 50% of work time in lab and 50% in office-based work.The incumbent is expected to be involved in the design, development, validation, and execution of bioanalytical assays for small and large molecules in a regulated environment.The incumbent is expected to independently develop and validate methods for regulated assays and develop and qualify fit-for-purpose bioanalytical assays for Alexion therapeutics at various stages of discovery and development.The incumbent will be focused on innovative approaches in method development, such as DOE and lab automation.In addition, the incumbent is expected to communicate cross groups and within cross functional teams, has persuasive writing and oral communication skills.The incumbent will closely collaborate with R&D, clinical, and non-clinical colleagues to fulfill bioanalysis for clinical, non-clinical and R&D studies.You will be responsible for:Function as a subject matter expert in the area of bioanalytical method developmentDrive the bioanalytical innovation by improving the quality and efficiency of method development and lab operationServe as part of the BA sub-team, working with Bioanalytical project lead to support discovery or development projects for method qualification/validation, data reporting, and interpretation of issues associated with the bioanalytical resultsTransfer qualified and fit-for-purpose assays to CROs and serve as the primary point of contact for assay transfer and troubleshooting of technical assay issues within project specified timelinesIntegrate quality standards to ensure that bioanalytical data is fit-for-purpose (e.g. GLP compliance at CROs for regulated analyses)You will need to have:Ph.D. in a relevant scientific field with a minimum of 0-3 years of biotechnology-related experience (may include post-doctoral experience); MS degree in relevant biological science field with a minimum of 8 years of experience; BS degree relevant biological field with a minimum of 11 years of experienceExperience with immunoanalytical methods, LCMS based methods and cell culture technique based assays for discovery supportExperience performing method development using Design of Experiments (DOE) and lab automationExperience in organizing and managing multiple bioanalytical projects in the laboratory settingScientifically independent - design, execute, analyze, interpret results, and reaches correct conclusionsWell organized, motivated, team player, and works with a sense of urgencyExperience in transferring assays to CROs, monitoring development/validation, and sample analysisWe would prefer for you to have:Experience in developing and validating bioanalytical assay in a regulated environmentExperience in regulatory submission, e.g. NDA, BLA and interactions with health agencies

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