Mesa Biotech

Scientist, Clinical Sciences

Mesa Biotech

6190 Cornerstone Ct E, San Diego, CA 92121, USA
Full-TimeDepends on ExperienceMid-LevelPhd or Professional
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.

Where is this job?
This job is located at 6190 Cornerstone Ct E, San Diego, CA 92121, USA
Job Qualifications
  • 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

Required Skills
  • Presentation skills

  • Writing Skills

  • time managment skills

  • Laboratory skills

  • Clinical statistical analysis

  • Validation skills

  • IVD product development and validation

Soft Skills
  • Self-Motivated

  • Communication Skills

  • Team Player Attitude

  • Detail oriented and highly organized

  • Process Oriented

Compensation

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.

Additional Information
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.
Required LanguagesEnglish
Job PostedJanuary 22nd, 2021
Apply BeforeJuly 8th, 2026
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About Mesa Biotech

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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