Senior Scientist, Molecular Diagnostics

 LOCATION: 

Baltimore, MD

POSITION SUMMARY:

This role is an exciting opportunity to be a critical part of a team developing rapid point-of-care molecular diagnostic (MDx) products. The position will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, and commercialization processes and specifically involve:

• Responsible for design of oligonucleotides used in product development 
• Lead R&D projects defining timelines and milestones for projects
• Design of experiment, hands-on execution, and documentation per QMS
• Present data and finding to scientific experts and management
• Work closely with cross functional teams and external collaborators
• Support internal workflow R&D
• Manage technical personnel

REQUIRED SKILLS: 

• Demonstrated experience modeling thermodynamic properties of oligonucleotide and modified probes binding to target sequences and optimizing amplification
• Experience implementing bioinformatics tools and databases for assay development, probe selection, and target site selection for mutation identification
• Experience in design transfer of MDx assay from R&D to manufacturing or third-party end-user
• Experience developing IVD MDx under design control for FDA submissions and commercial deployment experience with competitive landscape analysis 
• Proven track record of strong technical skills and hands-on experience with a diverse array of molecular and analytical testing methods
• Demonstrated expertise in nucleic acid manipulation, enzymology, and biochemistry as it relates to nucleic acid manipulation and characterization
• Ability to independently develop, optimize and validate analytical and clinical methods, specifically multiplex MDx assay methods
• Excellent communicator and presenter (technical and general).
• Strong organizational, interpersonal skills, and can-do attitude 

DESIRED SKILLS:  

• Study design experience for FDA 510k, PMA, or de novo IVD submissions
• Ability to code custom software tools 
• Assay development for point-of-care microfluidic systems 
• Experience with assay and instrument validation packages for GMP environment
• 2-4 years people management experience

EDUCATION:

• Ph.D. in Chemistry molecular biology, or a closely related field
• 3+ year of relevant scientific industry experience

TRAVEL REQUIREMENTS:

Professional conferences and events

  LOCATION: 

Baltimore, MD

POSITION SUMMARY:

This role is an exciting opportunity to be a critical part of a team developing rapid point-of-care molecular diagnostic (MDx) products. The position will provide an opportunity to participate in many aspects of in vitro diagnostics design, development, and commercialization processes but involves:

• Responsible for disposable cartridge and on-board chemistry value chain 
• Leads projects, defining timelines and milestones
• Defines and develops markets and customer experience
• Design of manufacture process, development of supply chain, and QMS interface; supports internal workflow for product commercialization
• Presents data and finding to scientific experts and management
• Closely works with cross functional teams and external collaborators

REQUIRED SKILLS: 

• Clear understanding of components and processes implemented in product line(s) for nucleic acid in vitro diagnostics in microfluidic cartridges
• Ability to independently develop, optimize, execute, and communicate project plans
• Clear understanding of market and access to customers
• Demonstrated capability of managing vendor relationships in delivery of in-bound materials and components used in product manufacture
• Broad technical experience related to product line(s) applied in support of internal and external customers and assures that customers receive high quality products and service
• Demonstrated capability in market assessment and partitioning
• Manage supply, demand, revenue, margin and pricing for product portfolio; update and present product line revenue forecasts to management, finance, and manufacturing teams
• Demonstrated capability for market introduction and growth for product line(s)
• Facilitates the day-to-day management of business initiatives in appropriate markets
• Excellent communicator and presenter (technical and general).
• Strong organizational, interpersonal skills, and can-do attitude will be needed in our fast-paced team.

DESIRED SKILLS:  

• Project design experience for FDA 510k, PMA, or de novo IVD submissions
• Ability to identify and implement process tools needed for internal and external customers
• Interpersonal skills related to delivery of technical products to end-user customers 
• Experience with regulatory requirements needed 

EDUCATION:

• MS or PhD in biomedical engineering or equivalent related to microfluidic IVD commercialization
• 3+ year of relevant in product management in an IVD development setting

TRAVEL REQUIREMENTS:

Professional conferences and events; sales support; vendor relations and audits

 LOCATION: 

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated Research Scientist to join our team to develop point-of-care molecular diagnostics for rapid detection of infectious pathogens. The ideal candidate should be able to execute and analyze experiments independently and with the guidance of Senior Scientists. The candidate will contribute to research and development of nucleic acid sample preparation, amplification, and detection of infectious pathogens. The position involves handling clinical samples e.g. urine, swabs, blood, and other potentially infectious materials.

REQUIRED SKILLS: 

• Experience in sample preparation and nucleic acids extraction methods
• Has experience in developing and optimizing nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR).
• Experience with handling clinical biological samples such as urine, swabs, saliva and blood
• Experience working in BSL-1 and BSL-2 laboratory
• Can work independently or with minimal supervision
• Ability to think outside the box and strong problem-solving/troubleshooting skills
• Experience with microfluidic assay development 
• Excellent documentation and communication skills

DESIRED SKILLS: 

• Experience in primer design and bioinformatics tools
• Experience with point-of-care molecular diagnostics 
• Experience with design of experiments (DOE) methods
• Experienced in IVD product development and FDA submission
• Experience in Microbiology a huge PLUS!

EDUCATION:

• Bachelor’s degree in life sciences with 3-5 years of relevant work experience   

                                                                                      OR

• Master’s degree (preferred) in life sciences with 1-3 years of relevant work experience

TRAVEL REQUIREMENTS:

None

 LOCATION:  

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated Research Scientist to join our team to develop point-of-care molecular diagnostics for rapid detection of infectious pathogens. The candidate will design and execute experiments with the guidance of the Director of Assay Development to develop multiplex nucleic acid lateral flow assay for endpoint analysis of amplified products. The main responsibilities include conjugate preparation, reagents dispensing, lateral flow strips assembling and assay optimization.

REQUIRED SKILLS: 

• Basic knowledge in chemistry, biochemistry and molecular biology.
• Experience in designing and preparing multiplex lateral flow assays. 
• Prior experience in protein conjugation and purification.
• Can work independently or with minimal supervision.
• Knowledge of experimental design and result interpretation
• Ability to think outside the box and strong problem-solving/troubleshooting skills. 
• Excellent documentation and communication skills. 

DESIRED SKILLS:  

• Experience in designing and testing multiplex hybridization DNA probes.
• Experienced in IVD product development and FDA submission.

EDUCATION:

• Bachelor’s or master’s degree in life science/engineering with minimum 2 years of Lateral Flow Development experience.

TRAVEL REQUIREMENTS: 

None

 LOCATION:  

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated Research Assistant Scientist to join our team to develop point-of-care molecular diagnostics for rapid detection of infectious pathogens. The ideal candidate should be able to execute and analyze experiments independently and with the guidance of Senior Scientists. The candidate will contribute to research and development of nucleic acid sample preparation, amplification, and endpoint detection of infectious pathogens. The position involves handling clinical samples e.g. urine, swabs, blood, and other potentially infectious materials.

REQUIRED SKILLS: 

• Experience in sample preparation and nucleic acids extraction methods.
• Has experience in developing and optimizing nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR).
• Experience with handling clinical biological samples such as urine, swabs, saliva and blood.
• Experience working in BSL-1 and BSL-2 laboratory.
• Can work independently or with minimal supervision.
• Ability to think outside the box and strong problem-solving/troubleshooting skills. 
• Excellent documentation and communication skills. 

DESIRED SKILLS:  

• Experience in primer design and bioinformatics tools.
• Experience with microfluidic assay development for point-of-care molecular diagnostics.  
• Experience with design of experiments (DOE) methods.
• Experienced in IVD product development and FDA submission.

EDUCATION:

• Bachelor’s degree in life sciences with 3-5 years of relevant work experience.

                                                                                       OR

• Master’s degree in life sciences with 1-3 years of relevant work experience.

TRAVEL REQUIREMENTS: 

None

POSITION SUMMARY:

Novel Microdevices is currently looking for highly motivated Staff Scientist to join our R&D team developing point-of-care molecular diagnostics for rapid detection of infectious pathogens. The candidate will contribute to research and product development of nucleic acid sample preparation, amplification, and detection of infectious pathogens. The position will also provide an opportunity to participate in many aspects of in vitro diagnostics design, development, manufacturing, and commercialization processes and specifically involve:

• Leading the design and validation of oligonucleotides for development of new IVD products 
• Independent experimental planning, design, hands-on execution, analysis, reporting, and documenting per QMS.
• Responsible for the planning, design, development, integration and qualification of assays on automated systems.
• Troubleshooting and problem solving
• Responsible for leading the design and execution of clinical studies to validate performance of the assays and providing relevant data and information in support of regulatory submissions. 
• Participate in defining project timelines and milestones
• Present data and finding to technical teams, scientific experts and management.
• Work effectively with cross functional teams and external collaborators
• May manage junior associates. 

REQUIRED SKILLS

• Demonstrated experience modeling thermodynamic properties of oligonucleotide and modified probes binding to target sequences and optimizing amplification assays.
• Experience implementing bioinformatics tools and databases for assay development, probe selection, and target site selection for mutation identification
• Experience in sample preparation and nucleic acids extraction methods.
• Experience in developing and optimizing nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR).
• Proven track record of strong technical skills and hands-on experience with a diverse array of molecular and analytical testing methods
• Excellent communicator and presenter (technical and general).
• Demonstrated experience leading technical teams
• Strong organizational, interpersonal skills, and can-do attitude
• Ability to work in a fast-paced R&D environment developing assays for multiple targets

DESIRED SKILLS

• Experience in FDA 510k, PMA, or de novo IVD submissions.
• Ability to code custom software tools.
• Ability to independently develop, optimize and validate analytical and clinical methods, specifically multiplex MDx assay methods.
• Assay development for point-of-care microfluidic systems.
• Experience with assay and instrument validation packages for GMP environment.
• 2-4 years people management experience.

EDUCATION

• Ph.D. in Chemistry, molecular biology, or a closely related field
• 2+ year of relevant scientific industry experience preferred

TRAVEL REQUIREMENTS

Professional conferences and events