Scientist 2, Biology
MillenniumSoft Inc
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Scientist III, 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 III is responsible for supporting the sustainment and continuous improvement of reagent and assay products throughout their lifecycle.
Primary responsibilities:
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
Serve as a technical subject matter expert 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
Minimum Qualifications:
Minimum of bachelor's degree in Life Science
Minimum 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Strong understanding of immunology, flow cytometry, assay development or related cell-based research technologies
Experience authoring and reviewing technical documentation
Demonstrated ability to lead projects independently and collaborate effectively across functions
Excellent written and verbal communication skills
Desired Qualifications:
Experience with flow cytometry-based diagnostic products
Experience supporting regulatory inspections and quality audits
Familiarity with design controls, risk management, verification/validation, and change control processes
Strong immunology, cancer biology and cell biology knowledge
Experience in reagent and assay development
Experience with product lifecycle management
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