**Roles and Responsibilities**
• Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding.
• Independently develop and execute bioanalytical or molecular assays (e.g. chromatography, electrophoresis/CE assays)
• Identify issues, lead troubleshooting experiments, and determine solutions with minimal to no guidance
• Train users on method execution, data analyses, and proper use of instrumentation
• Lead qualification and transfer of analytical methods to external stakeholders
• Routinely present work at team, technical team, and department meetings
• Maintain meticulous laboratory notebooks
• Analyzing, interpreting, and presenting data to internal and external stakeholders (Power Point Presentations)
• Author, review and approve technical documents, including methods, protocols, reports, and SOPs
• Deliver lifecycle-managed analytical methods for multiple programs with an understanding of ICH/FDA/EMEA best practices and current thinking.
• Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.
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