Staff Research Associate

Summary:

The Research Associate will support the development and optimization of viral genome (VG) titer analytical methods within the Analytical Development group. The primary focus of this role is hands-on molecular biology work, including droplet digital PCR (ddPCR), qPCR, and related nucleic acid-based techniques. This individual will work closely with the team to develop robust, phase-appropriate assays for gene therapy programs and will receive scientific and technical direction from senior scientists.

Duties/Responsibilities:

• Design, execute, and optimize VG titer assays using ddPCR (preferred) and/or qPCR platforms (e.g., QXOne, Bio-Rad)
• Perform primer and probe design and evaluate combinations for specificity, sensitivity, and reproducibility
• Conduct assay optimization studies including evaluation of cycling conditions, template input, and inhibitor effects
• Perform nucleic acid purification (DNA and RNA) from a variety of sample types using standard extraction methods
• Apply restriction enzyme digestion and other molecular biology techniques as needed for assay development
• Troubleshoot assay failures and inconsistencies; document root cause investigations and corrective actions
• Generate, analyze, and interpret experimental data; prepare clear and accurate technical reports and lab record
• Maintain compliant laboratory records in accordance with GMP/GLP documentation standards
• Collaborate with cross-functional team members (QC, Bioinformatics, Regulatory CMC) as directed
• Stay current with relevant scientific literature on ddPCR, NGS, and gene therapy analytics

Qualifications/Requirements:

Required:

• Hands-on experience with qPCR and/or ddPCR techniques, including assay setup, data analysis, and troubleshooting
• Experience with primer/probe design for PCR-based assays
• Proficiency in nucleic acid purification (DNA and RNA) and quantification
• Experience with restriction enzyme applications and standard molecular cloning technique
• Strong attention to detail; ability to maintain accurate and complete laboratory records
• Ability to work effectively in a fast-paced, collaborative environment under scientific direction
• Good written and verbal communication skills
• B.S. or M.S. in Molecular Biology, Biochemistry, Biotechnology, or a closely related life sciences field

Preferred:

• Experience with droplet digital PCR (ddPCR) specifically (e.g., Bio-Rad QX200/QXOne)
• Familiarity with next-generation sequencing (NGS): library preparation, instrument operation, or data QC
• Experience working with AAV or other viral vectors in an analytical or research context
• Experience in a GMP or GLP laboratory environment
• Familiarity with analytical method development and validation concepts
• Experience with JMP or other statistical software for data analysis