Senior/Staff Product Research Scientist, Molecular Diagnostics

Posted 1 month ago

LOCATION: 

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated and experienced product development scientist to join our R&D team as a key member in developing IVD point-of-care molecular diagnostics for rapid detection of infectious pathogens. The position is a technical lead role under the guidance of the Director of Assay Development and will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, manufacturing, and commercialization processes. The main responsibilities include:

  • Independently design and validate oligonucleotides for development of new IVD multiplex molecular diagnostic products
  • Independent experimental planning, design, hands-on execution, analysis, reporting, and documenting per GLP and QMS of multiplex molecular assays
  • Independent integration and qualification of molecular assays on automated microfluidic systems
  • Participate in design risk evaluation, mitigation and management
  • Adhere to FDA design control requirements for IVD product development
  • Design and execute analytical studies to verify product design and validate performance of the assays and provide relevant data and information in support of regulatory submissions
  • Actively participate in defining project activities and timelines to achieve project goals in a timely manner
  • Regularly present data and finding to technical teams, scientific experts and management
  • Effectively lead technical teams in the execution of project activities and work effectively with cross functional teams and external collaborators
  • Stay current with the science of infectious pathogens and molecular diagnostic products
  • May supervise junior associates

REQUIRED SKILLS:

  • IVD product development and FDA CFR 820.30 design control
  • Demonstrated experience leading technical teams
  • Proven track record of strong technical skills and hands-on experience with a diverse array of molecular and analytical testing methods
  • Optimizing sample preparation and nucleic acids extraction methods from multiple types of clinical samples for infectious pathogens
  • Designing and developing optimized multiplexed nucleic acid amplification and detection technologies (LAMP, PCR or RT-PCR)
  • Demonstrated experience modeling thermodynamic properties of oligonucleotide and modified probes binding to target sequences and optimizing amplification assays
  • Implementing bioinformatics tools and databases for assay development, probe selection, and target site selection for mutation identification
  • Microfluidic assay development
  • Excellent communicator and presenter (technical and general)
  • Self-starter with strong organizational, interpersonal skills, and can-do attitude
  • Ability to work in a results-driven R&D environment developing multiple products

DESIRED SKILLS:

  • Experience in FDA IVD study design and design transfer to manufacturing
  • Ability to code custom software tools

QUALIFICATIONS:

  • Degree in chemistry, molecular biology, or a closely related field
  • PhD plus a minimum of 2 years of relevant IVD molecular diagnostics product development experience
  • MS plus a minimum of 5 years of relevant IVD molecular diagnostics product development experience
  • BS plus a minimum of 8 years of relevant IVD molecular diagnostics product development experience
  • Minimum of two years leadership experience

TRAVEL REQUIREMENTS:

None

JOB TYPE:

  • Full time

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