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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.
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.
Your responsibilities include, but are not limited to:
* Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. * Plans and executes laboratory research. 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 * Conducts work in compliance with cGMP, safety and regulatory requirements. * Participates in activities such as RNA isolation, cDNA library construction, library amplification, genomic DNA isolation, polymerase chain reaction, and other standard molecular biology techniques. * Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings. * Able to troubleshoot experiments based on thorough understanding of assay principles * Authoring of technical reports and SOPs associated with the molecular assays developed and qualified . * Communicates and partners with cross-interdisciplinary teams to include, but not limited to engineering, regulatory compliance, scientists and other professionals * 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. * May act as spokesperson on corporate research and development and advise top management. * Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed * Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable. * Maintains broad knowledge of state-of-the-art principles and theories. * Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms. * Makes major contributions to scientific literature and conferences. * Other related job duties as assigned.