
Scientist, Clinical Sciences
Developing and optimizing Mesa’s in-vitro diagnostic device ensure proper quality and other clinical performance (FDA regulatory 510k/CLIA waiver) requirements are achievable. Perform reference clinical PCR assay and Real time PCR quantification method to test the analytical and clinical performance of Mesa’s IVD product. Developing clinical trial V&V protocol in collaborating with regulatory and CRO teams to verify and validate the performance of Mesa’s IVD product. Perform V&V testing to support the FDA approval of Mesa’s IVD product launch under ISO 13485 environment. Work with BSLII pathogen culture and perform hands on molecular biology laboratory and microbiology workflows and RNase-free handling. Work and communicate in an inter-department effort with engineering personnel to implement and test new design features and give the biological perspective on proposed engineering designs and impact to chemistry. Write and maintain standard operating procedures (SOPs), manufacturing instructions, quality control test methods, and experience with document control procedures.
Understand technical concepts of virology, microbiology and PCR
Familiar with IVD CLASS 2, FDA 510k regulatory, CLIA waiver guidance and product V&V
Experience of IVD product development and validation is a must.
Knowledge of infectious diseases or BSL-2 pathogens is a must
At least two years of post-doctoral research laboratory experience
Presentation skills
Writing Skills
time managment skills
Laboratory skills
Clinical statistical analysis
Validation skills
IVD product development and validation
Self-Motivated
Communication Skills
Team Player Attitude
Detail oriented and highly organized
Process Oriented
According to JobzMall, the average salary range for a Scientist, Clinical Sciences in 6190 Cornerstone Ct E, San Diego, CA 92121, USA is $130,000 to $180,000 per year. This salary range may vary depending on the individual's experience, qualifications, and other factors.
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Mesa Biotech is a healthcare test and data company that provides actionable information through trusted, PCR-based infectious disease testing. In 2021 Thermo Fisher Scientific acquired Mesa Biotech.

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