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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
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
Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations; Provide scientific leadership for the design
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving