Diagnostic Assay Development Scientist

Versiti, Inc.•Milwaukee, WI

1d•Onsite

About The Position

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).

Requirements

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
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
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

Nice To Haves

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 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
Previous experience with Laboratory Information Management Systems preferred
Demonstrated project management experience preferred

Responsibilities

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.
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.
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.
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.
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.
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.
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.