Sr Expert, Science & Technology (Analytical Project Lead)

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 Analytical Development Operations (ADO) group is responsible for developing analytical technologies and applying them to support viral vector development for cell and gene therapies. ADO supports chemistry, manufacturing and control (CMC) activities from the earliest stages of product candidacy through commercial licensure. Within ADO, the Senior Expert, Science & Technology, Analytical Project Lead (APL) is responsible for identifying critical quality attributes (CQA) of a viral vector candidate and developing analytical strategies and methods for monitoring CQAs throughout product development. The APL works within a cross functional CMC team to design, coordinate, and execute studies that demonstrate Novartis understands and appropriately controls the quality of our product and process. The APL position offers the opportunity to develop and apply rapidly advancing analytical technologies necessary to ensure Novartis consistently delivers safe and efficacious cell and gene therapies. <br><br>Your responsibilities include, but are not limited to:<br><br>• Produce product CQA assessment, analytical strategy, specifications, and comparability strategies/criteria<br>• Lead the development, qualification, transfer, and validation of analytical methods among multiple internal and external analytical laboratories<br>• Lead cross-functional and cross-site product characterization and investigations<br>• Provide technical expertise and leadership as you collaborate within and across cross-functional teams to support process development and establish control strategy<br>• Provide strategic recommendations across the network<br>• Serve as a key scientific and technical representative on cross-functional teams (CMC, Regulatory, Quality, Manufacturing, etc.)<br>• Write, review, and/or approve experimental protocols/reports and regulatory submissions<br>• Respond to questions from regulatory authorities regarding analytical topics and specifications<br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]