Sr. Scientific Expert- In vitro diagnostics
Role
The Senior Scientific Expert will join the Team in research and development of innovative products to support and strengthen the IVD immunoassay portfolio. The ideal candidate will have experience in developing in vitro diagnostic (IVD) products in a regulated environment.
A strong background in immunology/molecular biology is critical. The Senior Scientific Expert will be working with a broad cross-functional team and will be required to both support and lead internal and external research activities.
Your Tasks
• 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
• Research novel biomarkers that can be integrated or added as assays on existing product platforms, including ELISA, PCR, POCT and NGS
• Familiarity with bioinformatics tools
• Provide recommendations for innovative technologies and platforms to support QuantiFERON 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 global 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
Your Profile:
• Ph. D. degree in Microbiology, Immunology, Molecular Biology, or related field or MS 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/ machine learning tools is beneficial
• Ability to present to executive and senior leadership
• Able to connect science and business
• Excellent analytical, problem solving, time management and interpersonal skills
• Strong background in data analysis
• Strong capability to work in a collaborative team environment
• Strong organizational skills
Staffing and Recruiting
Research, Analyst, and Information Technology
Contract