The position is a technical lead role reporting to the Senior Scientific Research Manager 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)
Experienced with design of experiments (DOE) methods
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
Experienced 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 2 years of relevant IVD molecular diagnostics product development experience
MS plus a minimum of 4 years of relevant IVD molecular diagnostics product development experience
BS plus a minimum of 7 years of relevant IVD molecular diagnostics product development experience
Minimum of two years leadership experience
TRAVEL REQUIREMENTS: None