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