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Lead Research Scientist (Morrisville, NC) Duties: Engage in product development and innovation for in vitro diagnostics devices and rapid tests. Lead cross-functional teams through the full product development lifecycle from conception to commercialization for the organization’s current and future product line. Optimization of assays, troubleshooting of methods, support process development and transfer to manufacturing partners (including CROs or CMOs). Design and perform laboratory experiments, data analysis, and operating in a regulated environment. Design and execute laboratory experiments and analysis of data. Design and develop rapid diagnostic tests using microparticles and gold nanoparticles. Conduct hands-on laboratory and bench work and work independently in a GLP environment. Analyze product performance data, troubleshoot issues, and implement solutions. Maintain accurate laboratory and work documentation. Write technical lab reports with hypothesis, method, data collection, result analysis and conclusion. Aid in identifying root cause of production/manufacturing failures using structured problem-solving skills and applies fixes to prevent reoccurrence. Apply troubleshooting skills to tackle challenging engineering problems to improve productivity, quality, and/or product cost on existing product design and/or processes. Manage R&D projects of medical device design through verification, validation, regulatory submissions, and product launch. Coordinate with Quality Control team and Regulation team to ensure designs meet specifications and regulatory requirements. Responsible for compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes. Participate in product improvement and support manufacturing, as needed. Conduct literature reviews; summarize and evaluate obtained information. Maintain and promote good housekeeping (order & cleanliness) and safe behavior in labs. Accommodate additional tasks and responsibilities as needed.

 

Required: Master’s degree in Biomedical Engineering or related field.

 

Must have academic experience in the following areas as demonstrated by completion of graduate or undergraduate coursework and/or projects:

  • Working in a cGMP and/or cGLP environment
  • Lateral flow assay, PCR, ELISA, or immunoassay-based diagnostic devices
  • Medical device design control.
  • General medical device development including conjugation of nanoparticles to proteins, process development, assay performance optimization, and troubleshooting.
  • Immunoassay application to variable biomarkers.
  • Microfluidics, micromanufacturing, and nano/microparticle behavior.

 

 

Resumes to: BioMedomics, Inc., 1100 Perimeter Park Drive, Suite 104, Morrisville, NC 27560, Attn: Frank Wang or via email at Career@biomedomics.com.  Must reference position.