Scientist II, Analytical Development

Role: The Scientist II will independently design, optimize, and execute analytical research focused on AAV-based gene therapy programs. The primary objectives include developing and qualifying assays (e.g., potency, molecular methods like qPCR and ddPCR), supporting GMP manufacturing, material release, and regulatory submissions. Responsibilities encompass assay development, data analysis, technical troubleshooting, documentation, and cross-functional collaboration within CMC, Quality, and CRO teams. The role involves establishing AAV mechanisms of action, assessing assay performance risks, and contributing to regulatory documentation. Qualifications: BS in a relevant scientific discipline with 6-8 years (MS 4-6 years or PhD 1-3 years) industry experience, particularly in cell and gene therapy, with hands-on expertise in tissue culture, assay development, and data analysis. Knowledge of FDA, cGMP, ICH guidelines, and pharmaceutical validation is advantageous. The candidate should demonstrate strong organizational, communication, and problem-solving skills, with the ability to work collaboratively across teams in a fast-paced environment. High-value specifics include focus on gene therapy vectors, GMP compliance, regulatory support, and assay qualification. Work setup is not explicitly specified but implies a laboratory or office environment typical of biopharma R&D.