Manager - Senior Preclinical Qa jobs at Incyte in United States, Wilmington
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Establishes and maintains a strong relationship with Contract Packaging Organizations (CPO) in order to execute all planned activities in a timely manner. Prepares and recommends operating plans with CPO counterparts...
Conduct process analysis, simplification and intensification for APIs and their intermediates. Plan how to move laboratory synthetic procedures into a pilot production phase, then onto large-scale industrial processing. Develop methods...
Conducting internal and external audits to ensure all GLP/cGLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to. Perform Preclinical QA qualification and routine audits for all...
Contribute to the development of clinical development strategy for development assets. Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs...
Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines,...
Lead the opportunity assessment as it relates to licensing / acquisition of molecules in the autoimmune, inflammation and oncology therapeutic areas including assessment of preclinical and clinical data, analyzing market...
Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols. Write statistical analysis plans. Monitor internal and CRO project activities including timelines,...
Establishes and maintains a strong relationship with Contract Packaging Organizations (CPO) in order to execute all planned activities in a timely manner. Prepares and recommends operating plans with CPO counterparts...
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