Teiko.bio
Remote, Salt Lake City
Posted 3 weeks ago

Job Summary

We started Teiko Bio to use immune insights to help deliver life-changing therapies to those who need them most. Today, Teiko delivers on its mission by informing clinical decision-making.  By using cutting edge high-dimensional mass cytometry, Teiko’s leading assay, the TokuProfile, profiles the immune system of patients and predicts which ones are likely to do well on immunotherapy.

About you:

  • Familiar with high-throughput analyses, single cell analysis or flow cytometry assays
  • Motivated to help breakthrough therapies reach patients
  • Excited to tackle ground-floor challenges and work with seasoned scientists and proven entrepreneurs

The CLIA Lab Director in our Salt Lake City, UT facility oversees the operations and the quality of a wide range of clinical analyses in the hematology and immunology sections including diagnostic flow cytometry and a state-of-the-art mass cytometry instrument system. The CLIA Lab Director will be responsible for the development and maintenance of CLIA/CAP status of the laboratory and ensures compliance with applicable regulatory agencies at local, state and federal levels. 

Responsibilities

  • Oversee validation of the clinical TokuProfile Lab Developed Test, prepare validation documentation for appropriate regulatory bodies, and provide clinical and technical oversight for the testing and reporting of results
  • Use expertise in pathology, excellent communication skills, and energetic leadership to help expand a growing menu of blood-based tests for predictive medicine in the field of oncology
  • Work in concert with our scientists to make sure our tests are reliable and exceed regulatory standards for quality
  • Perform duties as required by CLIA regulations, including
    • Review of quality management systems, corrective action policies, etc.
    • Preparations for inspections
    • Review of validation reports
  • Assist ordering physicians as needed in interpretation of results
  • Work cross-functionally to support clinical test launches
  • Support the VP of Lab Operations with oversight of personnel and quality systems
  • Consistently demonstrate excellent clinical judgment and integrity

Qualifications

  • Doctoral degree in chemical, biological, or clinical laboratory science with current board certification or Utah licensed board certification in anatomical or clinical pathology
  • 2 years of Laboratory Director experience practicing CLIA compliance with specific lab training for high complexity labs and have successfully led a clinical laboratory through an inspection
  • Experience as technical supervisor and/or clinical consultant preferred
  • Problem-solving and decision-making skills, ability to appropriately confront and resolve issues
  • Ability to build teams, motivate individuals and groups
  • Ability to plan, organize and direct the activities of others
  • Excellent interpersonal and management skills
  • Excellent judgment and quality assessment skills

Location:

Remote with visits as needed in Salt Lake City, UT

Job Types:

Part-time, Contract

Apply Online