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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,
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
In this global role, the Industrial Lead Drug Product will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products (NBE and NCE). You will develop cutting-edge industrialization strategies,