Vaccine and Recombinant Product Safety Specialist

1 week ago


Parkville, Victoria, Australia CSL Full time

Within CSL's Research and Development department, the mission of Global Pathogen Safety is to develop and evaluate reduction strategies for viruses and other pathogens to provide products that our patients can trust and know to be safe.



As the global Product Owner for Pathogen Safety, you are responsible for defining the pathogen safety target profiles, establishing a pathogen safety by design framework based on Quality by Design principles, preparing pathogen safety submission data packages, and interfacing regulatory interactions for vaccine and recombinant products.



You will ensure that pathogen safety strategies are integrated into CMC strategies and project plans, and you will build strong partnerships with key stakeholders such as product development, regulatory affairs, and other functions across the organization.



Main Responsibilities and Accountabilities:




  • Responsible for the overall pathogen safety strategies for vaccine and recombinant products
  • Represents Global Pathogen Safety in cross-functional project and CMC teams


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