Principal Scientist - IVD Product Development

Principal Scientist – IVD Product Development Position located in Gaithersburg, MD Responsibilities of the Principal Scientist – IVD Product Development: Research novel biomarkers that can be integrated or added as assays on existing IVD product platforms, including ELISA, PCR, POCT and NGS Research adaptive immunity signaling pathways and kinetics of biomarker expression in response to antigen stimulation, with a specific focus on tuberculosis (TB) Understand current and emerging technologies in the field of TB diagnostics Familiarity with bioinformatics tools Provide recommendations for innovative technologies and platforms to support product portfolio Provide technical expertise as part of discussions with potential external collaborators. Lead meetings to outline new product opportunities with cross-functional teams including Business Development, Marketing, R&D, Clinical Affairs, Medical Affairs, Regulatory Affairs and Operations Support product lifecycle activities following design control processes for IVD regulated products, from feasibility, analytical and clinical validation in product development up to lifecycle management for registered products Lead R&D innovation team activities and fill role as primary R&D stakeholder on project teams Mentor and train junior scientists on product innovation concepts Requirements of the Principal Scientist – IVD Product Development: PhD in Molecular Biology, or related field with a minimum of 5 years of IVD industry experience In-depth knowledge of scientific discovery for biomarkers for infectious disease Experience with statistical software programs such as GraphPad Prism or JMP or Minitab Understanding of TB pathology and interaction with the host immune system recommended, but not required Experience with IVD product development in a regulated environment recommended. Experience with AI/ML tools is beneficial Commonwealth Sciences