Scientist, Analytical Development

Role: Lead analytical method transfer within Analytical Sciences, overseeing transfer strategies from development to GMP-compliant testing labs. Responsibilities: assess method readiness, design and execute transfer protocols, troubleshoot technical issues, and ensure compliance with GMP and regulatory standards (ICH Q2/Q14, USP). Collaborate closely with development, QC, regulatory, and external labs to optimize methods, improve robustness, and document transfer packages. Provide scientific support for deviations, investigations, and lifecycle changes; develop standardized transfer procedures and monitor performance trends for continuous improvement. Qualifications: Ph.D. in Analytical Chemistry, Biochemistry, or related field with 2+ years, or M.S. with 8+ years, or B.S. with 12+ years of industry experience in analytical development, QC, or pharmaceutical sciences. Skills: extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation across platforms such as chromatography, spectroscopy, or molecular assays, especially for biologics, vaccines, or advanced modalities like mRNA or gene therapy. Knowledge of GMP, regulatory expectations, and analytical lifecycle principles. Experience supporting deviations, lifecycle management, and cross-functional collaboration in regulated environments. Work Setup: 100% onsite; no travel specified. The role emphasizes scientific rigor, cross-team partnership, and continuous process optimization in a regulated biopharma setting.