Exagen is a patient-focused and discovery-driven life sciences company dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases. Our goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis, and monitoring of complex autoimmune and autoimmune-related diseases, including lupus and rheumatoid arthritis. By leveraging our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology, we help get to the real cause of a patient’s symptoms and guide their journey to improved health.

As a Scientist/Sr Scientist you will perform the development of new assays for diagnostics and research projects, from inception through planning and transfer to the clinical lab.

• Drive innovation in Pharma testing by integrating new techniques, technologies, and analytical approaches
• Demonstrates proficiency, competency & understanding of fundamental principles of clinical laboratory procedures.
• Assist with the development, optimization, and validation of new diagnostic assays.
• Participate in new technology evaluations.
• Collaborate with other members of the scientific staff within and outside the R&D group, including pharma clients.
• Complete all aspects of laboratory activities, including preparation, data acquisition, and analysis.
• Independently design experiments, perform data analysis, and troubleshoot technical issues relating to assay development and quality.
• Maintain accurate and complete records.
• Write standard operating procedures (SOPs) and other documents including validation plans & reports under CLIA/CAP guidelines.
• Comply with all company SOPs and safety standards.
• Maintain confidentiality of customer and patient information.
• Work effectively in cross-functional project teams in a multi-disciplinary environment.
• Maintains overall safety (including chemical & biological) of the department under established safety, infection control & procedure protocols
• Provides training, guidance & pertinent technical information to Scientists, Laboratory technicians, Assistants, and support staff.
• Appropriately addresses analytical and system performance.

Proteomic Multiplex Arrays development and Validation

• Design, develop, and optimize multiplex arrays for the detection and quantification of proteins, including enzymes and antibodies in biological matrices
• Validate methods in accordance with industry standards and regulatory guidelines
• Troubleshoot and maintain multiplex array instruments to ensure consistent and high-quality performance

Sample Analysis and Data Interpretation

• Interpret complex array data, ensuring accuracy in the identification and quantification of analytes
• Collaborate with biostatisticians and bioinformaticians to ensure robust data analysis and reporting

Minimum Qualifications:

• Ability to assist in advanced troubleshooting issues involving LIS, equipment, instruments, and assay performance.
• PhD in Molecular Biology, Chemistry, Biology, Immunology, Bioengineering or related field, with 4+ years of industry experience.
• Laboratory skills must include at least some of the following: proficiency in multiplex proteomic arrays, hands on ELISA experience, and hands-on Flow Cytometry experience.
• Must have good communication skills and attention to detail.
• Excellent time and project management.

Preferred Qualifications:

• 4-6 years wet-lab experience in Diagnostics, Biopharma or academic lab.
• Proficiency in use of proteomics arrays, multiplex arrays.
• Working knowledge of CLIA, CAP, and/or FDA regulations and Quality Systems.

Salary range: $100,000 - $135,000