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Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM; Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
Own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Review sterilization validations
You’ll play a vital role in the Biological Assays team using cell-based in vitro models or cell line culture and products in the GMP and GLP environment for biotech and pharma companies from Europe, the USA, and the rest of the world
Design and execute experimental studies to develop and optimise purification processes for biologics; Evaluate and implement advanced chromatography and filtration technologies for intensified downstream processing; Develop scalable purification