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Principal Scientist IVD Product Development
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Commonwealth Sciences, Inc.
Gaithersburg, MD (In Person)
Full-Time
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Job Description
Principal Scientist - IVD Product Development
Position located in Gaithersburg, MDResponsibilities 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 conceptsRequirements 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