Global Pathogen Safety Product Owner
7 days ago
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
- 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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Global Pathogen Safety Product Owner
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Parkville, Victoria, Australia CSL Full timeJob SummaryCSL is seeking a highly skilled Senior Manager to lead the Global Pathogen Safety team in the development and evaluation of reduction strategies for viruses and other pathogens. The successful candidate will be responsible for defining pathogen safety target profiles, establishing a pathogen safety by design framework, and preparing submission...
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