Scientist, Reagent and Assay Development

• The Reagent & Assay Development Group focuses on providing differentiated reagent solutions that uncover truths in biology and medicine. Teams of hardworking scientists are responsible for initiating and driving the reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical Flow Cytometry platforms.
• Products include cell analyzers, cell sorters, reagents, assays and software.
• The Scientist II is responsible for supporting the sustainment and continuous improvement of reagent and assay products throughout their lifecycle.

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• Support reagent and assay sustainment projects for marketed products
• Review and approve technical documentation to support reagent and assay products
• Review design history files, validation reports, risk assessments, technical files, and product specifications to ensure completeness and compliance
• Ensure documentation aligns with applicable quality system requirements and regulatory expectations
• Support change control activities and assess the impact of proposed product, process, or documentation changes
• Provide technical support during internal and external audits
• Support preparation of audit readiness activities and ensure technical documentation is inspection-ready
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operation teams to support business objectives

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• Minimum of bachelor's degree in Life Science
• Minimum 2 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

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• Demonstrated ability to collaborate effectively across functions
• Excellent written and verbal communication skills