Scientist, Clinical Sciences
Job Description
Job Description
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.
Equal Opportunity Employer
Mesa Biotech is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.