Job Details
Novartis
Senior Expert, Science & Technology (Drug Substance CMC 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>What you'll be doing:<br>• You will lead and coordinate the drug substance CMC sub-team and represent the drug substance process discipline in the global CMC project team of assigned programs <br>• You are accountable for managing all drug substance development activities including process development, tech transfer, GMP manufacturing technical support, etc.<br>• You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc. <br>• You will proactively identify scientific, technological and GMP issues and risk mitigation, propose creative solutions and communicate key issues to the appropriate management level<br>• You are responsible for high quality drug substance process registration documents for HA submissions and interacting with authorities, act as technical expert in audits, inspections etc.<br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]