Novel Microdevices is currently looking for a highly motivated Product Research Scientist to join our R&D team as a key member in developing IVD point-of-care molecular diagnostic assays for rapid detection of infectious pathogens. The position is a technical role on the assay development team under the guidance of the Senior Scientific Research Manager and will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, manufacturing, and commercialization processes. The main responsibilities include:
- Design, optimize, characterize and develop lateral flow assay components of the IVD microfluidic-based test cartridge for transfer to manufacturing.
- Experimental planning, design, hands-on execution, analysis, reporting, and documenting per QMS of multiplex nucleic acid lateral flow assay for detection of amplified nucleic acid products.
- Development, integration and qualification of lateral flow assays on automated systems.
- May participate in design risk evaluation, mitigation and management
- Adhere to FDA design control requirements for IVD product development
- Execute analytical and clinical studies to verify product design and validate performance of the assays and providing relevant data and information in support of regulatory submissions.
- Actively participate in defining project activities.
- Present data and finding to technical teams.
- Work effectively with cross functional teams.
- Knowledge in chemistry, biochemistry and molecular biology.
- Experience in designing and preparing lateral flow assays.
- Experience in protein conjugation and purification and handling nucleic acids.
- Experience with experimental design, result interpretation, and reporting.
- Ability to solve problems quickly by thinking outside of the box and effective troubleshooting skills.
- Excellent team and cross-functional communication skills.
- Strong organizational, interpersonal skills, and can-do attitude
- Ability to work in a results-driven R&D environment
- Experience in multiplex lateral flow assay development
- Experienced in IVD product development
- Experience in FDA IVD study design, design control and design transfer to manufacturing
- Experience in designing and testing multiplex hybridization DNA probes.
- Experience with microfluidic assay development
- Experience in a leadership role
- Advanced degree in relevant life science/engineering
- Worked in a regulated industry position