Sr Scientist - IVD Development

NuProbe USA Inc. is looking for a Staff/Senior Scientist to lead the IVD project development program at NuProbe to support both research and in vitro diagnostic (IVD) assays for use in medical research, clinical trials, regulatory submissions, and clinical diagnostic use. 

NuProbe USA is a rapidly growing company and the successful candidate will work with cross function groups to ensure compliance for NuProbe’s proprietary technology. This position reports directly to the Head of Regulatory Affairs and Quality Service.

NuProbe USA has a unique portfolio of assays including research use and in vitro diagnostic applications that include PCR, qPCR, Sanger, and NGS products. NuProbe is seeking highly motivated and competent individuals with the capacity to drive continuous improvement efforts. The ideal candidate has at least five (5) years’ experience in regulated medical device PCR/qPCR development.

RESPONSIBILITIES

• Develop PCR and qPCR IVD assays for FDA Class II and Class III indications in compliance with 21 CFR 820.30: Design Controls and ISO 13485.
• Lead Risk Assessment and Risk Management activities in compliance with ISO 14971: Medical devices - Application of risk management to medical devices
• Lead a IVD cross functional team to develop innovative IVD products and bring these products to market on time and under budget.
• Improve and establish state of the art design control practices.
• Design feasibility and analytical validation studies in agreement with scientific and statistical principles (where needed), regulatory requirements, and industry standards.
• Work with Clinical, Regulatory, and Quality to design and execute Clinical Validation Studies
• Analyze and develop thermodynamics-guided PCR assay designs; use mathematical simulations to predict and analyze best fit assay design; use MATLAB/Python code to analyze experimental results; utilize experimental results to re-design and optimize assay performance
• Supervise and lead bioinformatics and software development Scientists to develop data analysis algorithms for PCR, qPCR, Sanger, and NGS products for both research and diagnostic applications.
• Work with a Software Development team to translate research algorithms into requirement driven user-friendly graphical interface software and assay specific algorithms.
• Continuously improve Product Risk Management throughout the Product Lifecycle
• Control Research and Development IVD budget and associated resources
• Contribute to FDA submissions and direct communication with FDA as needed
• Other duties as assigned

EDUCATION & EXPERIENCE REQUIREMENTS

• Ph.D. degree, in Molecular Biology or related major
• Minimum of five (5) years of experience in the development and optimization of regulated IVD medical device assays
• Experience with successful FDA submissions (PMA, 510(k), etc.)
• Hands on laboratory experience with the PCR, qPCR, and NGS assays
• Strong technical writing skills
• Exceptional organizational and planning skills

PREFERRED BUT NOT REQUIRED SKILLS AND EXPERIENCE:

• Background in bioinformatics and knowledge of bioinformatics tools/database (GATK, NCBI, UCSC, Ensembl)
• Working knowledge of MATLAB and/or Python
• Experience in Oncology Research or Assay Development
• Experience with Companion Diagnostics a plus
• Experience with IVDR or MDR a plus

COMPENSATION AND BENEFITS

• Starting compensation from $110K - $130K depending on experience. For outstanding candidates, the starting salary can be negotiated
• 20% target bonus depending on performances
• Company benefits (medical, dental, 401k, unlimited PTO, etc.)
• Professional growth: At NuProbe, we believe in people, and we foster professional growth
• Contribute to the success of a rapidly growing startup

VISA SPONSORSHIP

NuProbe is willing to sponsor H1-b work visa for the successful candidate

About NuProbe USA:

NuProbe USA is the US-based R&D subsidiary of NuProbe Global, a company that recently raised $62M YTD to develop novel non-invasive DNA. Its technology enables precise and comprehensive capturing of disease signatures with uniquely high sensitivity and multiplexing capability. NuProbe technologies can reduce the cost of NGS by 50-fold and improve the sensitivity of qPCR, Sanger, and nanopore sequencing by over 100-fold. NuProbe's technologies and products are globally recognized, and NuProbe has multiple partnerships with leading sequencing companies such as Illumina, Oxford Nanopore, and QIAGEN, and hospitals such as MD Anderson, Baylor College of Medicine, and Yale School of Medicine. As a global company, NuProbe also has a China site based in Shanghai and cGMP facility in Suzhou. NuProbe is co-founded by Prof. Peng Yin at Harvard University, David Zhang (former professor at Rice University), and Dr. Victor Shi (former founding president of Qiagen Asia.