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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
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,
Project management of Cryo-EM projects (Gene-to-Structure) including customer interactions with international Pharma and Biotech companies in the US and EU. Lead the science and manage project teams composed of scientists from Protein Science and
Developing mechanistic assays to assess target biology, mode of action, and competitor benchmarks, thereby informing asset differentiation and strategic positioning. Independently designing, executing, and interpreting in vitro pharmacology studies from
Ensure compliance with international quality standards and regulatory requirements. Participation in regulatory inspections and external audits. Support the planning and execution of internal audits. Support with document control activities, including