Wondfo USA is currently seeking a Research Associate to fill an exciting position in our expanding Research & Development branch. This individual should have hands-on experience in molecular diagnostic assay development in an industrial setting, and will be conducting and supporting research projects that are essential for the feasibility and pre-market approval process of innovative molecular diagnostic products.
- Develop sample-to-answer molecular diagnostics assays from product concept through regulatory clearance, including initial development and feasibility activities, transferring to manufacturing, and verification and validation studies
- Execute experiments involving qPCR/RT-PCR, sample extraction, buffer formulation, assay integration
- Extract nucleic acid from various sample types, including difficult matrices
- Conduct experiments with live pathogens and human clinical samples in a biosafety level 2 laboratory
- Document results while keeping an organized and comprehensive experimental notebook
- Work collaboratively to foster professional, constructive relationships as part of a team to produce data and meet challenging timelines and goals
- Communicate results, orally and in writing, with colleagues and management
- Interact closely with cross- disciplinary teams, including other scientists and engineers
- S./M.S. in biology, molecular biology, biochemistry, or a related field
- Minimum of 3 years of product development experience in an industry position
- Ability to work independently in a fast-paced and collaborative multidisciplinary setting, while contributing to a supportive and positive work environment
- Good basic computation skills in Microsoft Office and experience using statistical software
- Previous experience in pre-market approval process, such as 510(k) and/or PMA is a plus
- Prior experience in the integration of molecular assays onto a diagnostic instrument is a plus
- Relocation package is not available for this position
Founded in 1992, Wondfo is a global company specializing on rapid diagnostics with laboratories in San Diego, Chicago and twelve overseas offices. Wondfo earned wide range of certifications from FDA CE, FSC, ISO 9001:2008 and ISO 13485:2012 quality system certification. Wondfo's sales network cover more than 140 countries and regions, providing an exciting opportunity for the distribution of quality products.
Wondfo strives to improve the quality of life and human health by developing and improving point of care in vitro diagnostic tests. At Wondfo USA's R&D site in San Diego, you will assist in designing and creating medical devices for the healthcare market. As a crucial part of a dynamic team, you will be involved in developing research ideas, executing experiments, and strategizing and developing these concepts into viable products.