Associate Product Development Scientist

 

Seeking highly motivated Product Development Associate Scientist/Engineer with industry experience in developing molecular assays. This position entails formulating, developing and optimizing molecular diagnostic assays, processes and methods. He/she will work cross-functionally within the Product Development, CLIA Lab Operations’ Teams and with outside resources, more specifically a major job function is to qualify reagents and performing preventative maintenance on equipment for the CLIA laboratory. The position will require independent research and the ability to execute a project plan and timeline. The candidate will be expected to communicate results effectively in both written reports and oral presentation. This position requires working well in a team environment and coordinating activities other team members to meet specific project milestones and deadlines. The Product Development Associate Scientist/Engineer will be part of a team responsible for the development, verification and validation of assays for clinical specimens in compliance with a LDT CLIA environment.

 

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

  • Perform molecular genetic testing on clinical specimens, including general sequencing and expression array analysis
  • Familiar with library prep for targeted sequencing (ThermoFisher or Illumina)
  • Assist in Analytical performance, Process and Test Method Validations
  • Develop quality control procedures for reagents and process controls for CLIA laboratory
  • Project planning, assay optimization, and technology transfer to the CLIA laboratory
  • Service and Installation of Capital Equipment including automation and sequencing platforms
  • Develop Equipment and Facilities Controls
  • Identify and correct problems that may adversely affect test performance, analysis, or reporting of assay results
  • Participate in activities associated with regulatory compliance and inspections
  • Work cooperatively in a team environment supporting senior laboratory and management staff
  • Work closely with the CLIA staff and QA/QC staff to transfer reagent processes and methods

 

POSITION REQUIREMENTS:

Education and Training:  

  • M.S. with 4+ years’ experience or BS degree with 6+ years in molecular biology, biochemistry, or related field

Experience:

  • Minimum of 4 years experience in molecular biology, biochemistry, or related field in assay or sequencing platform development
  • Broad experience in molecular biology techniques and/or automated instrumentation
  • Experience with development, verification, and validation study’s and the documentation process
  • Hands on experience with Oncology testing and a proven track record of developing diagnostic tests for CLIA laboratory
  • Industry experience strongly preferred

Knowledge and Skills:

  • Knowledge of molecular diagnostics preferred
  • Knowledge of statistical analysis and process control methods
  • Excellent interpersonal skills
  • Excellent problem solving skills
  • Demonstrated strength in tact and diplomacy with internal and external collaborators
  • Ability to work independently and exercise good judgment
  • Excellent teamwork and collaboration skills
  • Effective verbal and written communication skills

 

WORK ENVIRONMENT:

The work required for this position is to be performed onsite in a formal office/laboratory environment.

Please send your resume to careers@oncocyte.com if you would like to be part of this growing and dynamic team.