Diagnostic Assay Development Scientist

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

The Diagnostic Assay Development Scientist is primarily responsible for researching, performing, and interpreting experiments, in a cross-functional collaborative environment with moderate direction from leadership, to support the design and development of diagnostic assays offered by the organization (primarily focused on the transfusion medicine, transplant, and hematology fields). The Scientist also leverages their subject matter expertise and experience to troubleshoot and improve current diagnostic assays performed by the organization and to evaluate new potential technologies to implement within the testing environment. The Scientist may also support the training and professional development of other members of the department. This role may be associated with supporting one or more specific internal clinical testing laboratories (e.g., Immunohematology Reference, Histocompatibility, or Diagnostic Hematology).

• →Bachelor's Degree from an accredited college or university in biology, chemistry, molecular biology, immunology, clinical laboratory science, medical technology, or related field; AND 4+ years of relevant laboratory experience required
• →Master's Degree of Science from an accredited college or university in biology, chemistry, molecular biology, immunology, clinical laboratory science, medical technology, or related field preferred
• →PhD from an accredited college or university in biology, chemistry, molecular biology, immunology, clinical laboratory science, medical technology, or related field preferred

• 4-6 years Experience with new test development and assay troubleshooting in one or more of the following techniques/methodologies: nucleic acid work (DNA/RNA extraction, PCR/digital PCR, DNA/RNA sequencing [including next-generation sequencing], etc.); serologic and/or immunologic assays (ELISA, chemiluminescence, bead-based, etc.) required
• 4-6 years Experience working within defined Quality Management Systems, including formal validation and documentation policies and procedures required
• 1-3 years Experience serving as a subject matter expert (SME) to laboratory staff and/or other labs/departments (including training of/knowledge transfer to other personnel [e.g., SOP creation and training] required
• 4-6 years Experience in converting assays to new platforms (i.e., improved technology; high-throughput; etc.) preferred
• 1-3 years Prior experience mentoring scientific staff from a technical perspective, in a direct or indirect reporting relationship; AND/OR 4-6 years prior experience contributing to daily laboratory operations preferred
• 1-3 years Familiarity with and understanding of regulations related to CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Act), and quality assurance concepts/practices preferred

• Demonstrated ability, under moderate supervision from leadership, to design and execute experimental plans and to evaluate and ensure accuracy of data related to laboratory results required
• Strong detail orientation and analytical ability. Effective time management and organizational skills. Capable of planning, prioritizing and executing a broad base of laboratory functions and experiments, often across multiple simultaneous projects and with moderate oversight. required
• Able to deliver on organizationally-defined timelines and effectively communicate progress, challenges, etc. to stakeholders. Effective oral and written communication skills for both scientific and non-scientific audiences. required
• Ability to often work independently as well as part of cross-functional teams required
• Demonstrated decision-making, problem-solving, troubleshooting skills required
• Knowledge of good laboratory practices and quality systems required
• Previous experience with Laboratory Information Management Systems preferred
• Demonstrated project management experience preferred

• Personal Computer (desktop, laptop, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required
• Automated DNA sequencers, q/dPCR instrumentation, spectrophotometers, flow cytometer, DNA arrays, multi-well plate readers and washers, pipets, centrifuges, photo documentation, automated liquid handling systems required