Global Pathogen Safety Product Owner

7 days ago


Parkville, Victoria, Australia CSL Full time
Job Summary

We are seeking a highly skilled Senior Manager to lead our Global Pathogen Safety team. As the Product Owner for vaccine, recombinant, and cell and gene therapy-based products, you will be responsible for defining pathogen safety target profiles and establishing a pathogen safety by design framework based on Quality by Design principles.

Main Responsibilities
  • Develop and implement pathogen safety strategies for vaccine, recombinant, and cell and gene therapy-based products
  • Represent the Global Pathogen Safety team in cross-functional project and CMC teams
  • Build and lead GPS Execution teams in a matrix relationship with GPS Laboratories and Risk management team members
  • Provide product-specific pathogen safety strategy and manage its execution through collaboration with GPS Laboratories, Material Safety, and Operations support teams
  • Communicate GPS vaccine, recombinant, or cell and gene therapy-based product strategy to internal and external senior stakeholders and ensure adherence to GPS policies
  • Provide high-quality GPS data packages to regulatory authorities for relevant products
  • Maintain an overview of emerging industry and regulatory developments for relevant product classes
Qualifications and Experience
  • Postgraduate degree (MSc or PhD) in a relevant discipline
  • Minimum 5 years' experience in a biological pharmaceutical environment
  • Solid understanding of NPD and LCM in a biopharmaceutical environment
  • Proven track record in managing complex projects and strategy development
  • Experience working in cross-functional, multicultural, and international teams

CSL is committed to providing equal employment opportunity for all. We encourage you to make your well-being a priority. It's important and so are you.



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