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Lead and develop a multidisciplinary team of process engineers, specialists, and manufacturing professionals, fostering a culture of safety, quality, accountability, and continuous improvement. Take ownership of operational performance within the DSP
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;
Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for
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