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Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions. Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding,
The role is responsible for formulation design and process development across various modalities, with a focus on ADCs, within the Formulation Technology Research Laboratories (FTRL). Responsibilities include supporting the preparation of regulatory
Manage day-to-day QC lab operations, including raw materials, in-process, and final product testing; Lead analytical method qualification, validation, and transfer; Oversee analytical methods including flow cytometry, qPCR/ddPCR, and cell-based assays;
Fully accountable for planning execution of sterilization validation, cleaning validation, filter validation, shipping validation, temperature mapping and other validations. Manage investigations of complex validation deviations related to cleaning,
Drive continuous improvement initiatives, monitor quality performance metrics and identify opportunities to improve processes and team effectiveness. Ensure quality activities, including batch record review, quality event management and documentation, are