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Responsible for supporting the execution of the global medical plan for the assigned product in collaboration with the rest of the global medical team, as well as supporting the necessary cross-functional workstreams, while adhering to the
You will lead and manage the Medical Department ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical
Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable; Support the Head of Regional PV in the harmonization of processes across the regions
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
Use all imaginable chemistry tools and methods to develop and optimize commercial process for selected drug substance route (photochemistry, biocatalysis, flow chemistry, electrochemistry, on-line analysis/PAT, high-throughput experimentation, structural
This role is accountable for the vision, direction, and performance of the Bioanalysis and Immunoanalysis/Immunogenicity groups, ensuring the delivery of high-quality, regulatory-compliant data for pharmacokinetics, pharmacodynamics, and immunogenicity