This contract Research Associate supports clinical assay development activities through experimental execution and documentation support. 

Key Responsibilities 

• Execute assay runs supporting assay development 
• Execute assay runs supporting verification or feasibility studies 
• Prepare sample aliquots, controls, and calibration materials as instructed 
• Assist in reagent and buffer preparation 
• Assist in organizing data files and experimental records 
• Support repeat testing required for reproducibility or troubleshooting studies 
• Adhere strictly to controlled documentation practices 
• Manage sample and reagent inventory 

Qualifications 

• BS/MS with relevant laboratory experience 
• 2-3 years of experience working in research or clinical laboratories  
• Familiarity with working in structured or regulated lab environments 
• Strong documentation and organizational skills 
• Proficient in using Microsoft Office tools such as MS Word and Excel 

The base salary range for this full-time position is $30 - $40/hour. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

The IVD Assay Development Scientist will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications. This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization. 

Key Responsibilities 

• Lead development and optimization of IVD immunoassays on Alamar’s proprietary NULISA technology. 
• Design and execute experiments to optimize and troubleshoot assays to meet performance expectations. 
• Support technology transfer from R&D to manufacturing. 
• Define QC measures and support scale-up activities. 
• Work closely with Quality, Regulatory Affairs, and Engineering teams.  
• Participate in technical discussions and project meetings. 
• Design and execute verification and validation studies, including planning, laboratory testing, data analysis, and documentation of results. 
• Work closely with Quality, Regulatory Affairs, Engineering/Software, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness. 
• Support regulatory submission document preparation. 
• Contribute to Design History File (DHF)–aligned documentation.  
• Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies. 
• Perform other duties as required. 

Requirements 

• Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields. 
• 3–5+ years in IVD assay development and validation. 
• Hands-on experience with immunoassay formats (ELISA, chemiluminescent), enzymatic assays, and molecular techniques (qPCR, sequencing). 
• Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).  
• Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).  
• Excellent documentation and communication skills. 

The base salary range for this full-time position is $165,000 - $180,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.