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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
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;
Responsible for establishing and execution of work plans for their protein science area. Accountable for protein science project delivery from early drug discovery projects in their area of expertise, across modalities and therapeutic areas
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
Accountable for leading an injectable analytical group: developing, validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity