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This position reports to the Senior Staff Scientist within the Biological Sciences team of the Integrated Diagnostic Solutions – Specimen Management R&D organization. The scientist in this role will support activities for the development and verification of Specimen Management products for clinical diagnostic markets. As such, they will be responsible for the execution of laboratory studies that will be used to support regulatory submissions as well as evaluate new blood collection technologies as part of ongoing product development efforts. This scientist should have a strong understanding of human immunology and will be expected to become proficient in the areas of clinical hematology and coagulation.
Job Responsibility:
Design and execute experiments using applied biological sciences that further the development, verification, and evidence generation efforts across all assigned programs and projects
Execute and drive flow cytometry assay development/validation for regulatory submission studies
Maintain laboratory equipment including a BD LSR Fortessa X-20 flow cytometer and other instrumentation used in evaluating coagulation
Document and build technical knowledge within assigned business areas
explore and recommend solution concepts and principles when applicable
Own and drive key product development work streams including but not limited to Requirements Management, Design Verification, and Design Transfer to Manufacturing for applicable assignments
Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs, Manufacturing, Quality and Regulatory Affairs
Requirements:
B.S. 5+ years experience
M.S. 3+ years experience
Ph.D. preferred
Minimum of a B.S. in Cell/Molecular Biology or related field is required
Experience operating a BD LSR Fortessa X-20 flow cytometer required
Experience using FACS DIVA software required
Experience using FlowJo software required
Experience with flow cytometry sample preparation and whole blood staining required
Experience with isolation of peripheral blood mononuclear cells required
Must be proficient with MS Office
Excellent written and verbal communication skills and interpersonal skills
Strong learning agility
Self-motivated with a strong sense of urgency and willing to take hands-on work
Need US Citizens Or GC Holders Only
Nice to have:
Prior experience with flow cytometry assay development and validation strongly desired
Experience with handling clinical specimens (particularly human blood) is desired
Experience with statistical analysis tools is desired