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Senior Expert, Science & Technology (Sr/Scientist Molecular Biology) (341687BR)


Senior Developer



San Diego, California, United States

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>The Senior Expert, Science & Technology - MolBio, Initiates, directs and executes the Development and optimization of phase-appropriate molecular biology assays for the lot release, stability testing and characterization of drug substance/drug product. Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.<br><br>Your responsibilities include, but are not limited to:<br><br>• Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.<br>• Plans and executes laboratory research.<br>Initiates, directs and executes the development, optimization, qualification of robust molecular assays (i.e. NGS, qPCR, ddPCR and/or other molecular assay platforms) for DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AAV-based gene products<br>• Conducts work in compliance with cGMP, safety and regulatory requirements.<br>• Participates in activities such as RNA isolation, cDNA library construction, library amplification, genomic DNA isolation, polymerase chain reaction, and other standard molecular biology techniques. <br>• Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings.<br>• Able to troubleshoot experiments based on thorough understanding of assay principles<br>• Authoring of technical reports and SOPs associated with the molecular assays developed and qualified . <br>• Communicates and partners with cross-interdisciplinary teams to include, but not limited to engineering, regulatory compliance, scientists and other professionals<br>• Serve as SME of molecular assays in support of technology transfer of methods to internal QC group and/or CROs and subsequent trouble-shooting, as needed. <br>• May act as spokesperson on corporate research and development and advise top management. <br>• Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed<br>• Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable.<br>• Maintains broad knowledge of state-of-the-art principles and theories.<br>• Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms. <br>• Makes major contributions to scientific literature and conferences.<br>• Other related job duties as assigned.<br><br>[#video#{#400,300#}#/video#]