Expert (Scientist) - Science & Technology - Upstream

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>What you'll be doing:<br>• Leads and support activity with cross-functional organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. <br>• Provides support for process, analytical, and characterization knowledge related to the production of gene therapy products, and the raw materials needed to make them.<br>• Design and execution of time-sensitive experiments, studies, and capturing related data and knowledge, to advance the development products from Research to Development to GMP manufacturing. <br>• Ensures all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory filings. <br>• Tracks records of collaborative relations with groups such as research and development, analytical development, and pilot scale operations. Designs and applies DOE and QbD studies to develop, refine, optimize and characterize cell culture and vector production processes. Executes experiments and troubleshoot process and equipment. Conducts laboratory studies to enhance AAV manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).<br>• Writes detailed experimental protocols, develop Bill of Materials (BOM), executes and documents experimental studies according to Standard Operating Procedures (SOPs) or established practices, review and report data.<br>• Creates and revise SOPs for equipment and process operations.<br>• Lead the authoring of technical reports and CMC sections for regulatory filings.<br>• Supports initiatives for new technology development and continuous improvement projects.<br>• Maintains constant awareness of novel biochemical and biophysical technologies for AAV production and characterization. Keeps up to date with the scientific literature and developments in the field. Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. Justifies development strategies and experiment designs.<br><br><br>[#video#https://youtu.be/ggbnzRY9z8w{#400,300#}#/video#]