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Driving all aspects of purification process development, characterization, and technology transfer to cGMP manufacturing for hybrid and continuous processes; Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a
The candidate will serve as the bioanalytical expert for LC-MS and oversees outsourced LC-MS-based assay development, validation and sample analysis by bioanalytical vendors in support of regulated nonclinical and clinical studies for several of the
This leader oversees biomarker data modelling across scales (small scale to big data), establishes and applies QSP models in partnership with Pharmacometrics across sites, develops AI/ML approaches for tissue image analytics (IHC/ISH), and delivers
You’ll be leading a team of Pharmacometricians, from both a technical and scientific perspective, to ensure state of the art pharmacometrics approaches are applied to optimize drug discovery and development. Performing hands-on population PK/PD,
Review and evaluate clinical data generated from the imaging portion of sponsor clinical trials across various therapeutic areas. Maintain organized, complete, and up-to-date study documentation in accordance with internal and regulatory standards.