Diagnostic Assay Development Scientist

Versiti Blood Center of Wisconsin; Milwaukee (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Paid time off and holidays

401(k) with match

Job summary

Versiti Blood Center of Wisconsin in Milwaukee seeks a Diagnostic Assay Development Scientist to research, develop, validate, and interpret diagnostic assays used in transfusion medicine, transplantation, and hematology. You will troubleshoot assays, transfer methods to production, train staff, and collaborate across science and clinical teams.

A strong background in lab science, 4–6 years of experience, and education aligned with biology or medical technology are required or preferred.

Qualifications

• Bachelor's Degree in biology, chemistry, molecular biology, immunology, clinical laboratory science, medical technology, or related field with 4+ years of lab experience.
• Master's or PhD preferred in relevant field.
• 4–6 years experience in new test development and assay troubleshooting in relevant techniques.
• Experience with CAP/CLIA regulations and quality systems preferred.

Responsibilities

• Design, develop, validate, and launch laboratory-developed tests (LDTs) in transfusion, transplant, and hematology.
• Troubleshoot and optimize existing assays to improve performance and workflow.
• Transfer validated assays to production, and prepare design control documentation and regulatory submissions.
• Train staff and collaborate with internal/external stakeholders to advance assay development.
• Ensure compliance with regulatory requirements and maintain quality management documentation.

Skills

Assay development

Troubleshooting

Cross-functional collaboration

Regulatory knowledge

Training/education

Education

Bachelor's Degree in Biology/related field

Master's Degree

PhD

Tools

qPCR instruments

DNA sequencing

ELISA systems

LIMS

Job description

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 employees 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

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.).
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Qualifications

Education

• 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

Experience

• 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

Knowledge, Skills And Abilities

• 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

Tools and Technology

• 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