Scientific Research Manager

  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 
• Product Development experience in industry
• Management Experience

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 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 Associate to join our team to develop point-of-care molecular diagnostics for rapid detection of infectious pathogens. The selected candidate will be part of a highly innovative and interdisciplinary team, with an opportunity to learn about product development and research activities in an industry setting. The ideal candidate should be able to execute and analyze experiments under the supervision of the assistant and staff scientists. The selected candidate will maintain laboratory inventory and equipment, prepare buffers, reagents, and media. Will be involved in the research and development of nucleic acid sample preparation, amplification, and detection of infectious pathogens.

REQUIRED SKILLS:    

• Must have experience working in research or clinical laboratory settings
• Experience working in BSL-1 and BSL-2 laboratory
• Must have good lab techniques and documentation practices
• Excellent communication skills
• Must have a can-do attitude
• Team player willing to contribute to other groups as needed
• Passion for continuous improvement and learning new skills
• Ability to work on simultaneous projects as needed

DESIRED SKILLS:   

• Experience in sample preparation and nucleic acids extraction methods
• Experience in nucleic acid amplification / detection technologies (LAMP, PCR or RT-PCR) 
• Experience with handling clinical biological samples such as urine, swabs, saliva and blood

EDUCATION: 

• Bachelor’s degree in Biochemistry, Biology, Microbiology, Biotechnology, or related field with 0-2 years of relevant work experience. 

                                                                                       OR

• Have completed at least two years of study toward a bachelor’s degree in Biochemistry, Biology, Microbiology, Biotechnology, or related field. Must be in good academic standing. 

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

   LOCATION: 

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is currently seeking a Laboratory Technician to assist in manufacturing components of a new medical device. Under direct supervision, the selected candidate produces, cleans, and assembles plastic components per assembly SOPs, and performs other laboratory activities and maintenance.

PRIMARY DUTIES:

• Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions
• Maintain dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures.
• Prepare plastic sheets to be cut in a Laser cutter
• Cut and clean plastic parts using proper technique to support biological sample contact
• Assemble layered parts following a detailed assembly protocol in a clean environment
• Inspect (visual and using inspection tools) raw materials and well as finished products. Perform in-process inspection of components and assemblies to verify quality conformance
• Perform other duties as assigned such as laboratory maintenance, record keeping, packing, and storing inventory, etc. 
• Understand and adhere to safety policies and practices
• Clean and maintain equipment and work area as needed.
• Use tools such as microscopes, tweezers, and other hand-held tools.
• Recognize any minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors and Leads of issues and discrepancies immediately

REQUIRED SKILLS: 

• Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience
• Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Ability to read drawings
• Strong working skills with your hands
• Detail-oriented 
• Communicate effectively both orally and in writing
• Competent in Microsoft Word and Excel 
• Competency with computers and related software applications (Laser Cutter software for CAD/CAM)
• Ability to solve basic math problems

DESIRED SKILLS:

• Prior experience working with machine shop tools like CNC mill and LASER Cutter
• Experience working in a clean and regulated setting related to medical device assembly 

EDUCATION:

• Associates degree in engineering or related with 2+ years of experience
• 0-1 years of related experience

PHYSICAL ABILITY:

• Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
• Ability to work directly with, handle or come into contact with chemicals or reagents

TRAVEL REQUIREMENTS:

None

 LOCATION: 

Baltimore, MD

POSITION SUMMARY:

Novel Microdevices is looking for a Lead Software Architect to lead software development of our Molecular Diagnostic Product. You will need to be well versed and current in software development technologies and practices relevant to the Point of Care Diagnostics field and have a working knowledge of Industry norms with Cloud based Electronic Health Records/Patient Data Handling Systems as well as Instrument Firmware Development in accordance with IEC/ISO standards as related to Medical Device development and lifecycle management in an FDA regulated environment.

You will be required to use your knowledge, experience, and technical judgment to draft a development plan, software architecture and execution strategy and lead teams in our software development effort from concept through deployment and support. The role requires strong communication inside and outside of software engineering, and you will work across teams and organizations to ensure that products get delivered on-time with high quality.

This is a key leadership role in our organization that requires a seasoned person with a deep understanding of software technologies, industry trends and competitive offerings. The role entails a broad functional oversight on the development effort as well as a strategic component in planning and vision to launch Novel Dx as a world class diagnostic platform.

JOB RESPONSIBILITIES:

• Define the software vision and execution strategy for the software development effort; Influence R&D Software functional strategy on matters including core capabilities, software quality, software processes, resource development and utilization, and technology roadmaps.
• Seek partnerships and collaborate with cross functional product development teams to define software strategy, product roadmap and technology roadmap
• Influence the selection of technology, technology partners and development partners to ensure project success; Build and grow the software development team or seek competitive/competent contractors to help with the development effort
• Plan and lead technical development activities from concept through successful commercialization
• Ensure excellent planning and effective use of resources that will achieve organizational goals within established schedules, budgets, and product cost targets
• Take ownership of the Software development effort and be responsible for driving teams to deliver products on time
• Interact routinely with R&D Leadership on matters concerning software engineering technologies, development projects, and business milestones and effectively communicate progress toward project/program goals
• Lead or participate in design reviews and assess the ability of proposed designs to meet specified requirements.
• Develop Verification and Validation plans and coordinate the execution of V&V; Ensure compliance and the application of best practice software engineering methods to produce robust software designs
• Drive tactical and strategic planning for system/software architecture
• Provide technology assessment of competitive systems
• Provides input into yearly budget planning and ongoing resource planning

REQUIRED SKILLS:

• Familiarization and applied experience with IEC/ISO standards as related to Medical Device development and lifecycle management in an FDA regulated environment preferred.
• Experience in Healthcare and software development for Point of Care Diagnostic Devices
• Working knowledge of the requirements for Patient Data Handling/ Electronic health Records
• At least 5+ years of proven managerial experience
• Strong Interpersonal skills and Outstanding verbal and written communication skills, with the ability to explain complex technical problems to non-technical audience
• Experience with Agile Software Development

EDUCATION:

• Bachelor's degree in Software Engineering, or other STEM majors (Science, Technology, Engineering, and Math), with 10+ years of experience

                                                                                       OR

• Masters/Doctoral degree in related field with 8+ years of experience
• 5+ years managing people/vendors/partners

TRAVEL REQUIREMENTS:

Professional conferences and events