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Associate Director Science & Technology (Upstream Process Development)


Information Technology Director


San Diego, California, United States

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 Associate Director position- (Upstream, Drug Substance, Technical Research and Development), is responsible for the execution and management of process development activities in Gene Therapy at Novartis. Gene Therapies are a fast growing and exciting area of next generation medicines where our knowledge and impact are advancing rapidly. Our team has a large pipeline of innovative viral vector therapies and needs top talent to join our effort to develop molecules for clinical use to improve outcomes for many of our patients. We are looking for a candidate that seeks collaboration with their peers, values teamwork and can thrive in a multisite/multidisciplinary team of highly effective and focused scientists. <br><br>Your Key Responsibilities: <br><br>•Serving as a key scientific and technical representative for Upstream processing at internal sites, meetings and with external partners. <br>•Leads a diverse team of Upstream processing scientists in the technical R&D laboratory to deliver processes in support of new pipeline gene therapies. <br>•Builds and maintains a high performing staff of engineers and scientists to support ongoing process and pipeline development as well as process transfers to internal and external manufacturing sites.<br>•Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.<br>•Supports and develops the next generation manufacturing processes by planning to avoid delays, managing resources and leading activities to deliver a robust and effective product and process.<br>•Partners with Clinical, Manufacturing and Research to assure our process design supports safe and effective delivery to the patients.<br>•Partners with Regulatory and program leads to support submissions and approval of product applications.<br>•Reviews and provides feedback and technical/scientific support on project deliverables, (e.g. remediation initiatives, plan reports). Ensures all documentation and reports are accurate, complete, and suitable for using in support of development, characterization, and regulatory approval of products.<br>•Partners with Project Managers, Strategy Teams, Engineering, Supply Chain and others to anticipate and plan for budget and capex cycles, human and materials resourcing.<br><br>[#video#{#400,300#}#/video#]