Posted:2 months ago| Platform:
Work from Office
Full Time
We are looking for a highly motivated Project Leader Drug Substance to manage early phase projects from DRF tox batches up to first-in-human API deliveries. In this role you will closely collaborate with CDMO s in India but also work together with colleagues from other Novartis internal functions and sites. You will be part of the chemical and analytical development team at our site in Genome Valley and report to the local team leader Job Description Major accountabilities: To work with teams in the field of synthetic API development to support: 1. development of synthetic strategies to enable fast and reliable deliveries of API s for early phase development in close collaboration with our external CDMO partners in India Establish interdisciplinary project plans and track agreed activities with our key external partners in India and our Novartis internal stakeholders Ensure quality, quantity and timelines in all assigned projects Manage internal and external resource planning and allocation for assigned projects Advise team members and work according to appropriate SOP s, GLP, GMP, HSE and Novartis guidelines Ensure high quality of registration documents to enable timely IND/IMPD submissions. Interact with authorities where appropriate. Interact/collaborate with research and/or other functions in Development to facilitate transfer of knowledge and deliveries of API. Drive project handover to our internal late phase development site Minimum requirements: PhD and preferably postdoc in synthetic organic chemistry >10 years experience as a project leader in the chemical CDMO sector with strong process chemistry background Proven track record of expertise in the field of chemical process research and development incl scale-up of chemical processes till clinical phases Dedicated, thoughtful and flexible team working skills Excellent knowledge of English (oral and written) is required Good knowledge of common software applications and affinity to digital tools a plus
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