Duties & Responsibilities:
- Responsible to early research projects for the feasibility of prototype to be transferred to IVD assay development group.
- Analyze data, conduct 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.
Job Requirements & Attributes:
- 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.
Please contact email@example.com if interested.