Wondfo USA is currently seeking a Senior/Staff Scientist to fill the position currently available in our expanding Research & Development branch. This individual must have extensive hands-on experience in molecular diagnostic assay development in an industrial setting, and will lead a team of junior scientists from conceptual stage of assay development to supporting FDA and CFDA clearance upon successful project completion. Versatility and the ability to design and implement novel experiments, protocols, and technologies is required, in addition to mastery in data analysis. Strong written and verbal communication skills is a must, as this individual will also interact closely with cross-disciplinary teams, including chemists, engineers, and marketing specialists.
- Development of sample-to-answer molecular diagnostics from product concept through FDA clearance, including initial development and feasibility activities, transferring to manufacturing, and verification and validation studies
- Demonstrated expertise in the design, execution, and analysis (including various statistical analyses and DOE) of experiments with the ability to keep organized and comprehensive experimental notebooks
- Experience with oncological drug susceptibility screening of genomic mutations and rapid detection of human infectious diseases caused by microorganism pathogens using molecular diagnostic methods
- Experience with sample preparation/nucleic acid extraction from difficult sample matrices and sample-to-answer molecular diagnostic devices
- Experience with nucleic acid based technologies such as RT-PCR, qPCR, and isothermal chemistries
- Ability to work collaboratively fostering professional, constructive relationships as part of a team while also working independently to produce data and meet challenging timelines and goals
- Mentor Research Associates/Research Scientists in daily experiments and troubleshooting issues that arise using experience and knowledge
- Excellent organizations skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities
- Demonstrated ability to communicate effectively both orally and in writing with colleagues throughout all levels of the organization
- M.S./Ph.D in biology, molecular biology, biochemistry, or a related field with a minimum of 10 years product development experience in an industrial setting.
- Previous experience in pre-market approval process, such as 510(k) and/or PMA is a plus.
- Ability to work in a fast-paced and collaborative multidisciplinary setting, while contributing to a supportive and positive work environment.
- Ability to mentor junior scientists and team members, and maintain a professional and constructive working relationship with colleagues.
- Ability to travel 15%.
- Bilingual in English and Mandarin is a plus.
Wondfo strives to improve quality of life and human health by developing and improving upon point of care in vitro diagnostic tests. At Wondfo USA’s new R&D site, you will assist in designing and creating potentially life-saving 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