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Senior Fellow Analytics Biologics Early Phase Development

Inseriert am: 04.09.2018

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Apply to JobJob ID249239BRPosition TitleSenior Fellow Analytics Biologics Early Phase DevelopmentJob DescriptionTo develop our growing early phase New Biologics Entity (NBE) pipeline we are looking for an experienced professional in the area of physico-chemical analytics, protein characterization and CMC analytical strategy for early phase NBE projects. As a member of the Technical Development NBE Analytics leadership team, you will lead a team of analytical scientists and act as senior analytical expert for a large pipeline of monoclonal antibodies, therapeutic proteins and protein-conjugates.



Duties and Responsibilities:

•Act as a senior scientific leader for physico-chemical analytics and protein characterization.

•Design and develop CMC analytical strategies for the early phase NBE pipeline.

•Lead a team of analytical scientists (PhD and lab scientists) with the following tasks: project dependent analytical strategy, development of QC and protein characterization methods, method handover to QC, analytical comparability studies, and preparation of the analytical sections of regulatory CMC dossiers for PhI/II clinical trials.

•Lead and manage key scientific initiatives to develop short & long term CMC analytical strategies for a large NBE pipeline.

•Initiate and lead collaborations with Novartis internal and external partners.

•Drive Knowledge Management across the different groups, in close collaboration with the key interfaces, by defining, leading or supporting harmonization initiatives within Novartis Biologics.

Minimum requirements•PhD degree or equivalent in biochemistry, analytical chemistry or related field

•Minimum 8 years of successful industry experience in analytical development of physico-chemical methods, protein characterization and analytical project management.

•Senior expert knowledge in CMC analytical strategy for early phase NBE projects for PhI/II clinical studies e.g. antibodies, therapeutic proteins and protein conjugates.

•Successfully demonstrated track record of ideation, creativity and problem solving in projects.

•Strong presentation skills and scientific/technical writing skills.

•Advanced coaching skills.

•Excellent interdisciplinary thinking and proven ability to work in cross-functional, international teams.

•Excellent English (oral and written) required, German of advantage.DivisionGlobal Drug DevelopmentBusiness UnitTECHNICAL R & D GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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