Senior Manager, Global Pathogen Safety Product Owner Recombinant

Within CSL Research and Development department, the mission of Global Pathogen Safety (GPS) is the development and evaluation of reduction strategies for viruses and other pathogens to provide products that our patients can trust and know to be safe.

As the global GPS Product Owner for Vaccine, Recombinant and cell and gene therapy (CGT)-based products, you are responsible for defining the pathogen safety target profiles, establishment of pathogen safety by design framework based on Quality by Design (QbD) principles, preparing pathogen safety submission data packages and interfacing regulatory interactions for vaccine, recombinant or CGT-based Products.

You will ensure that GPS 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.

• Responsible for the overall pathogen safety strategies for vaccine, recombinant or CGT-based products
• Represents GPS in cross-functional project and CMC teams
• Builds and leads GPS Execution teams in a matrix relationship with GPS Laboratories and Risk management team members according to GPS Project Operating model
• Provide product specific pathogen safety strategy and manage its execution through collaboration with GPS Laboratories, Material Safety and Operations support teams including IP evaluation and due diligence support
• Communicate GPS vaccine, recombinant or CGT-based product strategy to internal and external senior stakeholders and ensures adherence to GPS Policies.
• Provide high quality GPS data packages to the regulatory authorities for the relevant product/sunder your specialty
• Maintain overview of emerging industry and regulatory developments for the relevant product class

• Postgraduate degree (MSc or PhD) in relevant discipline
• Minimum 5 years' experience in biological pharmaceutical environment
• A solid understanding of NPD and LCM in a Biopharmaceutical environment
• Proven track record in managing of complex projects and strategy development
• Experience working in cross-functional, multicultural and international teams