Scientist, Assay Integration

Organization: 
GenMark Diagnostics
Job Location: 
Carlsbad, CA
Job Description: 

Company Mission:
GenMark Dx’s mission is to become the market leader in providing high value, simple to perform, clinically relevant multiplexed molecular tests to aid in the diagnosis of disease and the selection and dosing of therapies. GenMark Dx’s proprietary eSensor® technology is based on the principles of competitive DNA hybridization and electrochemical detection. Our eSensor® technology is highly specific for the target biomarker and is not based on fluorescent or optical detection. As a result, our diagnostic tests are less prone to sample contamination risk and do not require many of the time-consuming washing and preparation steps required by competing multiplexing technologies.

Purpose of the Position:
The Scientist in the Assay Integration group is responsible for integrating existing and new assays onto fully automated sample-to-answer instrumentation currently in development.

Essential Duties and Responsibilities:
• Plans and executes laboratory experiments to design and develop automated molecular diagnostic assays including DNA/RNA extraction, PCR amplification and detection.
• Participates in cross-functional teams as part of the overall product development project. Works effectively in multi-disciplinary teams to design, optimize, test and troubleshoot assay performance parameters.
• Troubleshoots experiments to identify and solve assay issues to maximize the assay performance and robustness.
• Collaborates with Regulatory and Clinical departments to conduct and document the studies necessary for Class II and III IVD worldwide regulatory submissions.
• Conducts product development activities in accordance with the Quality System, Design Control and Product Development Process requirements and best practices.
• Ensures fact-based scientific, engineering and analytical best practices and principles are utilized to accomplish goals.

Key Qualifications & Experience Requirements:
• Ph.D. in Molecular Biology, Microbiology, Biomedical Sciences or related field plus 3 years of experience in molecular diagnostic assay development, Master’s degree plus 5 years of experience or Bachelor’s degree plus 10 years of experience.
• Experienced as a molecular scientist for diagnostic assay development projects on microfluidic devices.
• Demonstrated experience in troubleshooting assay and instrument integration issues.
• Specific expertise in sample extraction and PCR amplification techniques is required.
• Experience with design control, risk assessment, manufacturing processes and product specification development is required.
• Experience with reagent stabilization, such as lyophilization or similar stabilization techniques.
• Experience as a member of product development team conducting concurrent development of new automated systems and molecular assays is desired.
• Training and experience in statistical data analysis, JMP and Design of Experiments methodology is desired.
• Demonstrated capability as a scientific writer that can create the design output defined by the Product Development Process and best practices.
• Planning and detail follow-up skills needed. Demonstrated ability to execute to a timeline.
• Comfortable working in a fast-paced, dynamic environment while juggling multiple project priorities.
• Ability to work effectively in a team environment with the ability to relate to multiple disciplines and functions.

AN EQUAL OPPORTUNITY EMPLOYER
All employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, age, creed, ancestry, marital status, non-job-related handicap or disability, veteran status, or any other legally protected status.