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Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits; Conduct internal audits to assess the compliance of AbbVie quality management
You will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio - from pharmaceuticals and medical devices to
Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams for specific topics;
In this role, you’ll provide global scientific and technical leadership, contribute to innovation strategies, and act as a thought leader - both within Lonza and the wider biopharmaceutical industry. Guide development of mammalian USP/DSP processes for
Lead key projects in mammalian cell line development, while spending the majority of your time (~80%) performing hands-on lab work; Mentor and support junior scientists within the team, fostering skill development and knowledge sharing; Contribute to the
In this role, you will be responsible for applying biology knowledge in an engineering environment to support product development of novel systems used in biopharmaceutical development. This involves working in a multidisciplinary team to achieve the