Clinical Laboratory Director

CSI® seeks a clinical molecular biologist with next generation sequencing experience in a CLIA-certified lab to be a key member of CSI®’s laboratory team, reporting directly to the Executive Vice President of Research & Development. This position will ensure the safety and compliance of our lab and personnel, as well as the development and delivery of associated testing and training. This role is responsible for the quality assurance (QA) and quality control (QC) of our wet lab systems’ standard operating procedures (SOP)s, equipment, test reporting and employee adherence to all requirements as indicated by CLIA requirements and CAP proficiency program. Appropriate physical and environmental conditions for testing, as well as ensuring instrumentation is performing to specifications, will be monitored by this position.

Employees at all levels are expected to:

  • Be enthusiastic learners and advocates of our technology, products and services
  • Drive results and growth
  • Respect and promote inclusion and diversity
  • Do what’s right for each other, our customers and their patients, our investors and our communities

Position Requirements

  • Satisfy one of the following minimum requirements:
    • M.D. or D.O. licensed to practice in Pennsylvania and certified in anatomic or clinical pathology or possesses qualifications equivalent to those required for certification
    • M.D. or D.O. licensed to practice in Pennsylvania and have at least one year of laboratory training during residency or at least two years of experience directing or supervising high complexity testing
    • Doctoral degree in a chemical, physical, biological, or clinical laboratory science and certification by a board approved by the Department of Health and Human Services
    • Doctoral degree in a chemical, physical, biological, or clinical laboratory science and, before February 24, 2003, served as director of a high-complexity clinical laboratory with at least two years of laboratory training and/or experience and two years of experience directing or supervising high complexity testing
    • Served as a Laboratory Director or could have qualified to serve under regulations in effect on or before February 28, 1992
  • Minimum two (2) years post-graduate experience in a high-complexity testing lab, two (2) years associated CLIA experience
  • Prior experience in molecular diagnostics, with a strong working knowledge of CLIA, CAP and Pennsylvania state and federal regulatory requirements
  • Next Generation Sequencing experience (Illumina platform), required
  • Strong working knowledge of molecular biology protocols (e.g., PCR, qPCR, library preparation, Bioanalyzer, biochemistry, GCMS, HPLC)
  • Proven track record of proactive planning and subsequent compliance of personnel, equipment and instrumentation to CLIA and CAP requirements
  • Meticulous attention to detail; strong problem-solving skills
  • Exceptional written and verbal communication skills
  • Experience working in a startup environment

Disclaimer: The above information has been designed to indicate the general nature and level of work performed by employees in this role. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications.