Staff Product Research Scientist, Molecular Assay Development

Posted 4 weeks ago

POSITION TITLE:
Staff Product Research Scientist, Molecular Assay Development.

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 diagnostic assays for rapid detection of infectious pathogens. The position is a technical lead role under the guidance of the Director of Assay Development and reporting to the Senior Scientific Research Manager. It 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
  • 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)
  • Expert with using design of experiments (DOE) methods in assay development
  • 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
  • Expert in the molecular mechanisms of pathogenesis and resistance in human infectious diseases
  • 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 6 years of relevant IVD molecular diagnostics product development experience
  • MS plus a minimum of 8 years of relevant IVD molecular diagnostics product development experience
  • BS plus a minimum of 11 years of relevant IVD molecular diagnostics product development experience
  • Minimum of 2 years broad leadership experience

 

TRAVEL REQUIREMENTS:

  • None

 

JOB TYPE:

  • Full time

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