Scientist

The Scientist I/II will support the development, optimization, qualification, and execution of analytical methods used to characterize gene therapy products and support process development and manufacturing activities. The ideal candidate will have hands-on experience with molecular biology techniques, particularly PCR-based assays, along with a background in analytical testing, assay development, or product characterization. This role will contribute to analytical method development and troubleshooting while supporting routine testing and the transfer of methods into GMP environments.Primary ResponsibilitiesDevelop, optimize, and execute analytical methods to support gene therapy process development, product characterization, and manufacturing activities.Perform molecular, cell-based, and immunological assays, including PCR-based techniques such as qPCR, ddPCR, and/or dPCR.Support the development, optimization, verification, qualification, and transfer of analytical methods into GMP testing environments.Conduct in-process testing and product characterization to evaluate viral vector attributes, including vector genome quantification and process- or product-related impurities.Design and execute experiments to assess product quality, investigate analytical challenges, and support process development activities.Analyze and interpret experimental data, identify trends, troubleshoot assay performance, and communicate results to cross-functional teams.Prepare and maintain technical documentation, including test methods, protocols, experimental records, and technical reports in accordance with applicable quality standards.Collaborate with Process Development, Manufacturing, Quality, and analytical testing teams to support project goals and program timelines.Contribute to continuous improvement initiatives involving analytical methods, laboratory processes, and testing capabilities.Maintain laboratory equipment, reagents, and materials while ensuring a safe, organized, and compliant laboratory environment.Education, Experience, & QualificationsBachelor's or Master's degree in Molecular Biology, Biochemistry, Cell Biology, Biotechnology, Immunology, or a related scientific discipline.Approximately 2–6 years of relevant laboratory experience in biotechnology, pharmaceutical, or related life sciences environments.Hands-on experience with molecular biology techniques, particularly PCR-based assays such as qPCR, ddPCR, and/or dPCR.Experience with gene therapy, viral vectors, or cell and gene therapy products is highly preferred.Previous experience with analytical method development, optimization, troubleshooting, or qualification.Familiarity with analytical testing and characterization techniques, including immunoassays, ELISA, cell-based assays, or other molecular and biochemical methods.