Diagnostic Assay Development Scientist

Responsibilities

• Assay Design, Development, Validation & Launch
• 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.).
• Supports the efforts of key departmental point(s) of contact for these partnerships; in certain circumstances, may serve as the key point of contact.
• 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.
• Represents assay development team at select internal planning, strategy and logistics meetings.
• 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.

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.
• Experience working within defined Quality Management Systems, including formal validation and documentation policies and procedures required.
• 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).
• Experience in converting assays to new platforms (i.e., improved technology; high-throughput; etc.) preferred.
• Experience in 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.
• Familiarity with and understanding of regulations related to CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Act), and quality assurance concepts/practices preferred.