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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;
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
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