Scientist 2, Biology

Bill Rate $79.13 ON site Excited to grow your career?

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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