Scientist (Assay Development)

Organization
Vela Diagnostics
Job Location
353C Route 46 West
Fairfield, NJ 07004
Job Description

· Responsible to early research projects for the feasibility of prototype to be transferred to IVD assay development group.

· Analyze data, perform trouble shooting for issues during feasibility and development stages.

· Technically gate for test protocols / strategies for feasibility and development tests to ensure project developed in the most productive way.

· Ensure integration of hardware, software and chemistry for automated workflow is properly and timely done before entering development phase.

· Ensure all the research activities which lead to development work to meet FDA QSR and ISO 13485 requirements.

· Work closely with scientists, product managers, Bioinformatics and engineers in Vela's R&D department in Singapore.

· Ensure the assays developed in R&D are manufacturable, cost effective and user friendly.

· Patent filing and IP management.

· Prepare publications.

Requirements

· Ph.D. in Biochemistry, Microbiology, Genetics, Molecular Biology, Medicine or a related biomedical science area.

· Minimum 5 years of hands on experience and track record of molecular diagnostic assay development, preference in Industrial setting.

· Experience in ISO 13485 desired.

· At least 5 years experience in development of real-time detection multiplex PCR / RT-PCR assays.

· At least 3 years experience in development of NGS products.

·  In-depth knowledge of FDA requirements for design control and risk analysis desired.

· Training and experience in statistical analysis and Design of Experiment methodology.

· In-depth knowledge of molecular biology, including searching and analysis of genetic databases, principles of PCR and NGS and Enzymatics.

·In depth understanding the steps and technical requirement for assays development, detail oriented, desire and drive to the perfection of the products. 

· Strategically, organizational and detail follow-up skills required.

· Ability to trouble shoot and working out solutions for any technical challenges.

· Ability to understand complex scientific, engineering and business concepts and importance of the integration elements in workflow.

· Demonstrated ability to be flexible and resourceful.  Excellent communication skills.

· Proven direct management skills.

· Passion for science and technology, inspiring and influential to team. · Knowledge of safety precautions required for working with pathogens at Biosafety Level 1 and 2.

How to Apply

Please send your application to hr@veladx.com

 

About Our Organization

Vela Diagnostics is a worldwide provider of innovative and integrated diagnostic workflows for the screening, diagnosis and monitoring of disease. Our solutions serve the needs of hospitals, reference laboratories and bio-medical research to deliver value by optimizing processes and facilitating medical decision making. We achieve this by delivering extended and standardized test menus on consolidated platforms, supported by industry experienced professionals, committed to meeting the individual needs of our customers.

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