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Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations; Provide scientific leadership for the design
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving
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,