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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. Based on training progression and competency the Principal Scientist will be expected to apply for ASHI Director In-Training (DIT) status and ACHI Board Certification (required for PhD candidates) and subsequently obtain full ASHI and ACHI Director Certifications per an outlined DIT plan.

Overview:
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.

Position Summary:
Under the direction of the Senior Director, Histocompatibility, the Principal Scientist will train in the HLA lab in all areas of Versiti Wisconsin ASHI lab accreditation. The Principal Scientist is expected to complete all required reading, educational activities, laboratory observation, interaction and hands-on training and participate in clinical case reviews as requested by the Director. As competence is obtained the Principal Scientist will participate in on-call management rotation and will be accountable for helping to provide leadership to the Histocompatibility Laboratory, with a focus on clinical care, diagnostic innovation, education, and operational excellence. Based on training progression and competency the Principal Scientist will be expected to apply for ASHI Director In-Training (DIT) status and ACHI Board Certification (required for PhD candidates) and subsequently obtain full ASHI and ACHI Director Certifications per an outlined DIT plan. The DIT is expected to submit a completed ASHI case study portfolio to the ASHI DTRC (Director Training, Review and Credentialing Committee) within the timeline provided, and to obtain ASHI Director certification soon after completion of the training period. Achievement of ACHI Diplomate board certification by written exam is also expected prior to submission of the ASHI portfolio to the ASHI DTRC as outlined in the ASHI-approved training plan. Finally, as a DIT the Principal Scientist will be expected to also contribute to the successful execution of business and strategic initiatives; ongoing and sustainable improvements in the areas of compliance, customer/employee satisfaction; and process improvement.

Total Rewards Package:
Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities:
<ul><li>Clinical and Scientific Leadership * Reviews clinical cases and provides clinical consultation when deemed competent (including on-call). * Stays current with and contributes to best clinical practices in histocompatibility and transplantation, serving as an expert resource for the lab. * Identifies new technologies and/or tests that will add value to customers and patients, and participates in their development, validation, and/or operational implementation. * Ensures own ongoing professional development through presentations and professional meetings. * Achieves professional certifications [F(ACHI), ASHI, etc.] at completion of training period</li><li>Product Development and New Test Implementation * Identifies, evaluates, and implements opportunities for new or improved laboratory tests. * Assists with validation planning, execution and summary as needed. * Under guidance of Senior Director, helps monitor performance of newly introduced tests and methods. Initiates action when inconsistencies or problems are identified.</li><li>Laboratory Operations * Demonstrates partnership and collaboration with operational management through participation and discussion, and alignment with organizational/team goals and decisions. * Functions as a productive member of the laboratory leadership and director teams. * Partners effectively with the Diagnostic Assay Development (AD) team and contributes to innovation efforts. * Serves as a technical resource to the laboratories for problem solving and process improvement.</li><li>Regulatory Responsibility & Quality Assurance * When deemed competent, responsible for performing technical supervisor responsibilities per Clinical Laboratory Improvement Act (CLIA) ’88 regulations and as delegated per the Senior Director. * Responsible for helping to ensure laboratories meet all applicable standards (ASHI, CAP, NY, etc.) * Participates in developing and executing quality systems for laboratory operations, ensures that QC (quality control) and safety procedures are managed effectively. * Participates in test performance and QA (quality assurance) program review. * Helps ensure successful participation in proficiency testing.</li><li>Customer Service * Develops and maintains relationships with customers; solicits and communicates customer needs and issues to laboratory operations and ensures they are addressed. * Provides expert consultation and interpretation to customers in a timely manner. * Promotes interdepartmental cooperation and respect through effective communication and problem solving. * Provides educational lectures locally and nationally on request. * Shares in the responsibility of training residents, fellows, SBB students & other visitors to the lab.</li><li>Planning * Contributes to operational plans which support the organizational strategic direction. * Helps ensure current standards and emerging concepts are incorporated into annual planning.</li><li>Continuous Improvement Culture * Champions continuous improvement to create customer value more efficiently and effectively.</li><li>Financial Management * Develops a general understanding of laboratory financials (budgets, etc.). * Participates in the financial analysis of new opportunities.</li><li>Leadership * Participates as an effective member of the Diagnostic Laboratories scientific team. * Communicates effectively with staff, management, and customers. * Manages change constructively.</li><li>Human Resource Management * Supports and promotes a culture of open, productive communication and responsibility in the laboratories. * Responsible for staff development in science, technology and leadership, to include, ongoing learning, and development of personal and departmental performance standards to meet business unit initiatives.</li><li>Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification</li><li>Understands and performs in accordance with all applicable regulatory and compliance requirements</li><li>Complies with all standard operating policies and procedures</li></ul>

Qualifications:
Education<ul><li>Medical degree (M.D. or D.O.) with board certification in clinical or combined anatomic/clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, required</li><li>PhD in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution, required</li><li>PhD only candidates must be ACHI Laboratory Director board eligible based on education and training or experience in immunology, histocompatibility, immunogenetics or a related field as outlined in the current edition of the ACHI Candidate Handbook. required</li><li>PhD only candidates must also meet current CLIA education requirements for a high complexity laboratory director and current ASHI DTRC (Director Training, Review and Credentialing committee) requirements for all DIT (Director-In-Training) candidates as outlined in the most current ASHI standards. required</li></ul>Experience<ul><li>1-3 years Minimum of 2 years’ post-doctoral training or experience in immunology, histocompatibility, immunogenetics or a related field as required to meet current CLIA educational requirements as well as ASHI and ACHI DIT credentialing guidelines. required</li></ul>Knowledge, Skills and Abilities<ul><li>Scientific expertise in the field of histocompatibility, molecular biology, and immunology. required</li><li>Excellent interpersonal, communication and organizational skills. required</li><li>Creative, with “can do” attitude; innovative problem solver. required</li><li>Strong detail orientation and analytical ability. required</li><li>Laboratory experience with flow cytometric and molecular methods. preferred</li><li>Strong analytical ability to evaluate and ensure accuracy of data related to quality control and process improvement. required</li><li>Effective verbal and written communication skills. required</li><li>Ability to work in partnership with others in a collaborative team environment. required</li></ul>Tools and Technology<ul><li>Personal Computer (desk top, lap top, tablet) required</li><li>General office equipment (computer, printer, fax, copy machine) required</li><li>Microsoft Suite (Word, Excel, PowerPoint) required</li></ul>#LI-EH1#LI-Hybrid

Versiti, Inc.

Principal Scientist Histocompatibility Lab

Analysis Skills

Assay Development

Best Practices

Budgeting

Business Strategy

Change Management

Clinical Laboratory

Clinical Medicine

Clinical Pathology

Clinical Practices/Protocols

Clinical Validation

Communication Skills

Continuous Improvement

Cost Control

Customer Satisfaction

Customer Support/Service

Data Quality

Develop and Maintain Customers

Financial Analysis

Financial Management

Genomics

Healthcare

Healthcare Providers

Hospital

Hospital Systems

Human Resources Management

Identify Issues

Immunology

Interpersonal Skills

Laboratory

Laboratory Operations

Laboratory Testing

Leadership

Medicine

Microsoft Excel

Microsoft PowerPoint

Microsoft Product Family

Microsoft Word

Molecular Biology

On Call

Oncology

Operational Support

Operations Management

Operations Planning

Organizational Skills

Pathology

Patient Care

People Management

Performance Analysis

Performance Testing

Presentation/Verbal Skills

Problem Solving Skills

Process Improvement

Process Safety Management

Product Development

Quality Assurance

Quality Assurance Methodology

Quality Control

Regulations

Regulatory Compliance

Sales Management

Sales Qualification

Staff Development

Standard Operating Procedures (SOP)

Stem Cells

Strategic Planning

System Operations

Team Player

Technical Leadership

Test Plan/Schedule

Testing

Time Management

Training/Teaching

Validation Plan

Writing Skills

[AW]-iCims

Position Summary: 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). 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.

Overview:
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.

Position Summary:
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).

Total Rewards Package:
Compensation The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications. Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities:
<ul><li>Assay Design, Development, Validation & Launch. Collaborates with laboratory leadership to propose new and modified laboratory developed tests (LDTs) and prioritize ideation, feasibility, development, design transfer, validation, and launch. In specific cases, may serve as a champion for innovative diagnostic assay concepts. Supports the evaluation of project needs and the planning and performance of tasks, ensuring project completion within designated timeframes and meeting all Versiti and regulatory requirements. Provides technical input to and supports laboratory staff in the execution of delegated assay-related activities. Performs and interprets experiments independently and presents findings to team members and stakeholders. Prepares and/or assists in the preparation of assay-/project-related documentation (such as design control documents, SOPs, regulatory agency submissions) in accordance with organizational policies/procedures and regulatory requirements.</li><li>Troubleshooting, Optimization & Continuous Improvement. Leverages technical experience and expertise to partner with laboratory leadership and staff to identify and correct performance-related aspects of existing assays. Identifies opportunities for improving assays (reduced turnaround time, reduced cost, etc.) and operational workflows.</li><li>Technology Innovation and Knowledge Maintenance. Maintains an understanding of current trends in lab practices and business climate, relevant to the organization’s clinical focus and applies the acquired knowledge and skills in contributing to the structure and planning of projects. Reviews and applies relevant scientific and clinical literature in supporting strategy decisions. Engages with vendors to identify and evaluate new and/or improved technologies which can support the ongoing and future-state testing capabilities of the laboratories. May represent organization at scientific conferences (requiring occasional domestic and/or international travel), serving in both the role of presenting new research findings/assay offerings as well as in identifying opportunities for new technologies and assay development.</li><li>Training & Instruction. Serves as a technical resource for lab(s) in areas of specialized expertise. Trains clinical laboratory staff on execution of new and modified assays to be validated and implemented; includes relevant and applicable methodology and associated aspects critical to assay execution (equipment, software, documentation, etc.). Serves as a subject matter expert on specific projects and provides technical input for other members of department.</li><li>Collaboration with Internal and External Parties. Represents assay development team at select internal planning, strategy and logistics meetings. Collaborates in a cross-functional manner with other scientists, clinicians, laboratory operations staff, and support groups (e.g., Information Systems, Marketing, Business Development, Bioinformatics) to advance assay development projects through effective communication and adherence to project timelines. Collaborates with internal (i.e., other divisions of the organization) and external (i.e., clients and collaborators) technical liaisons to support and promote technology assessments and assay development research and execution (which may include development, validation and launch activities described above); facilitates technology transfer into lab(s), as necessary. Supports the efforts of key departmental point(s) of contact for these partnerships; in certain circumstances, may serve as the key point of contact. Occasional domestic travel may be associated as part of this responsibility.</li><li>Costing and Budgeting. Assists laboratory management in the development of annual operating and project-specific budgets. Supports Marketing, Business Development, Finance and related departments in establishing assay costing and business case analyses for current and future tests and procedures.</li><li>Specialized Testing and General Lab Operations. Performs specialized testing for laboratory-specific research, clinical testing, contract research, and other special projects, as needed. Supports day-to-day operations of department (equipment maintenance, document management, supply ordering, etc.).</li><li>Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification</li><li>Understands and performs in accordance with all applicable regulatory and compliance requirements</li><li>Complies with all standard operating policies and procedures</li></ul>

Qualifications:
Education<ul><li>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</li><li>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</li><li>PhD from an accredited college or university in biology, chemistry, molecular biology, immunology, clinical laboratory science, medical technology, or related field preferred</li></ul>Experience<ul><li>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</li><li>4-6 years Experience working within defined Quality Management Systems, including formal validation and documentation policies and procedures required</li><li>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</li><li>4-6 years Experience in converting assays to new platforms (i.e., improved technology; high-throughput; etc.) preferred</li><li>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</li><li>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</li></ul>Knowledge, Skills and Abilities<ul><li>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</li><li>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</li><li>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</li><li>Ability to often work independently as well as part of cross-functional teams required</li><li>Demonstrated decision-making, problem-solving, troubleshooting skills required</li><li>Knowledge of good laboratory practices and quality systems required</li><li>Previous experience with Laboratory Information Management Systems preferred</li><li>Demonstrated project management experience preferred</li></ul>Tools and Technology<ul><li>Personal Computer (desktop, laptop, tablet) required</li><li>General office equipment (computer, printer, fax, copy machine) required</li><li>Microsoft Suite (Word, Excel, PowerPoint) required</li><li>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</li></ul>

Diagnostic Assay Development Scientist

Assays

Bioinformatics

Biology

Business Case

Business Development

Chemistry

Clinical Research

Clinical Support

Conferences

Cross-Functional

DNA Sequencing

Design Document

Detail Oriented

Digital Polymerase Chain Reaction (Digital PCR)

Document Management

Documentation

Environmental Sciences

Equipment Maintenance/Repair

Establish Priorities

Experiment Design

Finance

Hematology

High Throughput

Immunohematology

Information Technology & Information Systems

Knowledge Transfer

Laboratory Information Management System (LIMS)

Laboratory Management

Laboratory Techniques

Logistics

Marketing

Mentoring

Multitasking

Needs Assessment

Next Generation Sequencing (NGS)

Nucleic Acid

Operations

Polymerase Chain Reaction (PCR)

Project Evaluation

Project Planning

Project/Program Management

Quality Management

Regulatory Requirements

Regulatory Submissions

Research Contracts

Research Laboratory

Sales Prospecting

Technical Support

Technology Analysis

Test Lab

Validation Documentation

Vendor/Supplier Selection

Willing to Travel

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Principal Scientist Histocompatibility Lab Versiti, Inc.

Diagnostic Assay Development Scientist Versiti, Inc.

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