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Role Summary
The Research Associate I - HLA/SLA (Xeno/RMO) is responsible for assisting developing, validating, and performing immunogenetics testing to support xenotransplantation research and regulatory milestones. This role focuses on performing assays to characterize swine leukocyte antigen (SLA) and human leukocyte antigen (HLA) compatibility, optimizing crossmatch and antibody screening assays, and ensuring high-quality, reproducible data to guide clinical and preclinical decision-making. The position plays a key role in advancing translational research by collaborating with multidisciplinary teams to refine protocols, analyze results, and support regulatory submissions.
Responsibilities
- Perform routine and complex immunogenetics testing (e.g., PCR-based typing, Next-Generation Sequencing, Luminex/Intelliflex assays) on human and porcine samples
- Assist in development, validation, and optimization of assays for histocompatibility testing (HLA/SLA)
- Isolate, culture, and prepare PBMCs, endothelial cells, and other relevant cell populations for compatibility testing
- Troubleshoot technical issues, maintain assay performance, and document deviations or corrective actions
- Maintain and calibrate laboratory equipment, ensuring readiness for regulated testing and audits
- Contribute to scientific manuscripts, abstracts, and conference presentations
- Stay current with relevant literature, technologies, and regulatory guidelines in HLA/SLA testing and xenotransplantation research
- Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements
- Assist in writing, reviewing, and updating SOPs, validation protocols, and quality records
- Participate in internal audits, CAP inspections, and regulatory reviews
- Assist in training junior staff and collaborators in proper laboratory techniques and assay workflows
- Collaborate with clinicians and R&D scientists to design experiments and refine donor–recipient matching strategies
Qualifications
- Minimum: Bachelor’s Degree in a related field
- Minimum: 1+ years of histocompatibility experience
- Proficiency in laboratory techniques (pipetting, cell handling, molecular assays, flow cytometry)
- Capacity to participate in multiple projects with competing timelines in a fast-paced research and clinical environment
- Effective problem-solving skills to troubleshoot assay failures and identify root causes
- Competence with electronic laboratory notebooks (ELN), LIMS systems, and basic bioinformatics workflows
- Ability to work flexible hours including evenings and weekends on an ad hoc basis
Preferred Qualifications
- ABHI - American Board of Histocompatibility and Immunogenetics Certified Histocompatibility Technologist (CHT) or Supervisor (CHS)
- Strong understanding of immunogenetics, including HLA and SLA systems, antigen presentation, and transplant immunology
- Familiarity with xenotransplantation models, including swine genetics, immunobiology, and donor-recipient matching considerations
- Working knowledge of cell culture techniques, including PBMC and endothelial cell isolation and maintenance
- Knowledge of crossmatch methodologies (CDC, flow cytometry) and interpretation of cytotoxicity/antibody binding data
- Excellent technical documentation skills for SOP writing, assay reports, and regulatory submissions
Education
- Bachelor’s Degree in a related field
Additional Requirements
- Onsite role requiring 5 days per week in the Morrisville, NC location