Sr. Director, R&D
DiaCarta
I am Qing Sun, Ph.D., currently Sr. Director, R&D at DiaCarta Inc. My prefessinal qualification highlights are below.
More than 20 years of microbiology/molecular biology/genetics/ skills and experience in R&D in academic and IVD diagnostics industry and CLIA accredited clinical laboratories and BSL-2 laboratory
• Proficiency in Nucleic Acid Technology: Possess hands-on experience and expertise in nucleic acid technologies, including PCR, qPCR, multiplex PCR, and digital PCR, etc., demonstrated ability to design assays, plan experiments, and perform data analysis.
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Product Development Expertise: Proven track record in establishing plans and protocols for product feasibility testing, optimization, verification, validation, and launch, demonstrated ability to drive product development processes and ensure successful outcomes under design control and quality management system
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Experience in IVD product regulatory submissions, including FDA 510(k) pre-sub, EUA and CE-IVD, etc. Successfully led the development and validation of multiplex RT-qPCR based SARS-CoV-2 detection assays approved by FDA EUA (EUA200176 and EUA200575), which is one of the top 5 high sensitivity tests among all EUA approved molecular diagnostic tests for SARS-CoV-2
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Excellent laboratory organization skills including project planning and management, lab preparation, equipment maintenance.
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Significant ability to write complex technical reports, papers published in journals and periodicals. Prepare documents and address questions from FDA for regulatory submission, pre-submissions.
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Critical Thinking and Problem-Solving: Possess strong critical thinking skills with a growth mindset, demonstrated ability to analyze complex problems, think creatively, and develop innovative solutions in a dynamic work environment.