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Responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsible for preparing and managing CMC regulatory
Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.). Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH,
Leading the development and manufacture of inhaled drug delivery systems, including dry powder inhalers and pressurised metered-dose inhalers (pMDIs); Inputting into manufacturing processes strategies from concept through scale up to commercialisation;
Lead, plan, and coordinate daily cell and tissue culture activities in compliance with GMP standards. Supervise and mentor a team of (Senior) Biotech Associates, ensuring quality and efficiency in manufacturing. Initiate and follow up on deviations,
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