Senior Laboratory Technologist - Assay Development

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$33.60 - $46.20

By joining Exosome Diagnostics, a Bio-Techne brand (NASDAQ: TECH), you will have an impact on future cutting-edge research. Exosome Diagnostics is a liquid biopsy company that harness the power of Exosomes as a multi-analyte component of Liquid Biopsies. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Schedule:        Monday – Friday, Possible Saturday   

  

The Opportunity

This position will be responsible for planning and executing on partnered development projects for both internal and external collaborations.  Technology transfer, operationalization, verification, and validation, of nucleic and protein assays are all in scope. 

Secondary responsibilities may include performing high complexity testing for our clinical laboratory.  

May also function as General Supervisor (CLIA), and Supervisor (NYS) overseeing Testing Personnel in the laboratory.  Individuals must therefore meet all the educational & experiential thresholds for Testing Personnel (CLIA), General Supervisor (CLIA), and Supervisor (NYS) in a high complexity laboratory.

ESSENTIAL FUNCTIONS

• Development of novel assays intended for diagnostic use at Exosome Diagnostics (ExoDx),
• Verification/Validation of assays that are FDA-approved, EUA-approved, FDA-modified, or laboratory developed tests) for use in the Assay Transfer & CLIA laboratory at ExoDx.
• Development Verification/ Validation of assays for Partnered Research projects
• Collaborate with cross-functional teams to ensure successful assay development and implementation.
• Analyze and interpret experimental data and present findings.
• Prepare protocols, technical reports, and documentation for internal record and/or regulatory submission.
• Conduct and document training for internal teams.
• Manage critical inventory for current and future projects.
• Document all corrective actions taken when established policies and procedures deviate from the laboratory’s established performance specifications.
• May be asked to perform high complexity molecular biology procedures under the direction of the Clinical Operations Manager and Laboratory Director
• Follow the laboratory’s procedure for specimen handling and processing, test analyses, reporting and maintain records of patient test results
• Be capable of identifying problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the titled General Supervisor, Technical Supervisor, or Laboratory Director
• Maintain detailed, accurate and up-to-date lab records
• Use appropriate laboratory safety procedures in performance of duties, including the use of personal protective equipment
• Maintain laboratory equipment per standard operating procedures

Knowledge, skills and abilities

• Ability to train and lead other technologists
• Ability to monitor key metrics
• Excellent organization and attention to detail
• Ability to implement policies, and execute detailed procedures as directed.
• Work productively in a team environment.
• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point
• Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)
• Strong interpersonal skills that include excellent skills in written and verbal communication, collaboration, and problem solving with other departments and colleagues
• Experience with a Laboratory Information Management System (LIMS)

Education and Experience:

Supervisory Qualified

This position may have supervisory responsibilities and therefore candidate must meet the New York State thresholds to fill that role. Candidates who meet this threshold must also participate in Supervisor Competency program to the extent they had delegated responsibilities.

 A candidate must:

Hold a Bachelor of Science Degree in a chemical or biological science and 4+ years of experience in a molecular clinical laboratory, OR

Hold a Bachelor of Science in Medical Technology and 4+ years of experience, OR

Hold a Master of Science in Chemical or Biological Science and subsequent to graduation at least 2 years of molecular clinical laboratory OR

Hold a Doct