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.
Main Responsibilities and Accountabilities:
Responsible for the overall pathogen safety strategies for vaccine, recombinant or CGT-based productsRepresents GPS in cross-functional project and CMC teamsBuilds and leads GPS Execution teams in a matrix relationship with GPS Laboratories and Risk management team members according to GPS Project Operating modelProvide 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 supportCommunicate 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 specialtyMaintain overview of emerging industry and regulatory developments for the relevant product class Qualifications & Experience:
Postgraduate degree (MSc or PhD) in relevant disciplineMinimum 5 years' experience in biological pharmaceutical environmentA solid understanding of NPD and LCM in a Biopharmaceutical environmentProven track record in managing of complex projects and strategy developmentExperience working in cross-functional, multicultural and international teams We are looking forward to receiving your application. Applications must include a motivation letter and CV.
Applications Close on 14 July 2024
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About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.
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