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You will be responsible for managing the required quality activities and documentation associated with the portfolio of CMOs, ensuring that the CMOs manufacture and deliver products in compliance with Sanofi’s requirements specifications and regulations
Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics are in accordance with the relevant GMPs. Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial
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,