Senior Manager, Global Pathogen Safety Product Owner Recombinant
4 days ago
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 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
Qualifications & Experience:
- 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
We are looking forward to receiving your application. Applications must include a motivation letter and CV.
Applications Close on 14 July 2024
CSL is committed to providing equal employment opportunity for all.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL
CSL 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.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL
-
Parkville, Australia CSL Full timeWithin 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,...
-
Finance Officer
3 weeks ago
Parkville, Australia University of Melbourne Full time**Job no**: 0062353 **Location**:Parkville **Role type**:Full-time; Continuing (continuing research contingent) **Faculty**:Medicine, Dentistry and Health Sciences **Department**:Cumming Global Centre for Pandemic Therapeutics / The Peter Doherty Institute for Infection and Immunity **Salary**:UOM 6 - $92,749 - $100,397 p.a. plus 17% super - _they have been...
-
Finance Officer
1 month ago
Parkville, Australia University of Melbourne Full timeAbout the Role Based within the Directorate of the Peter Doherty Institute for Infection and Immunity, the Finance Officer will manage financial administration for externally funded projects, including those supported by DFAT and the Cumming Global Centre for Pandemic Therapeutics. Collaborating with an international network of partners, the role...
-
Research Assistant
3 weeks ago
Parkville, Australia University of Melbourne Full time**Job no**: 0055468 **Location**:Parkville **Role type**:Full-time/ Fixed-term for 2 years **Faculty**:Faculty of Medicine, Dentistry and Health Sciences **Department/School**:Department of Microbiology and Immunology **Salary**:Level A - $80,258 - $108,906 p.a. plus 17% super - **Collaborate with leading experts in a renowned pathogen genomics research team...
-
Product Manager
2 weeks ago
Parkville, Victoria, Australia University of Melbourne Full timeJob no:Location:ParkvilleRole type:Full time / ContinuingDepartment/School:Business ServicesSalary:Senior Manager 1 ; circa 200k package incl. 17% super Expand your portfolio by joining Australia's leading university Take the major part in designing and delivering of platform solutions across the university Leading a highperforming and passionate Product...
-
Product Manager
3 weeks ago
Parkville, Australia University of Melbourne Full time**Job no**: 0051717 **Location**:Parkville **Role type**:Full time; Continuing **Faculty**:Faculty of Business and Economics **Department/School**:Melbourne School of Professional and Continuing Education (MSPACE) **Salary**:UOM 8 - $110,709 - $119,829 p.a. plus 17% super The University of Melbourne would like to acknowledge and pay respect to the...
-
Medical Scientist Grade 2
1 month ago
Parkville, Australia The Royal Melbourne Hospital Full timeMedical Scientist - Grade 2 Victorian Infectious Diseases Reference Laboratory (VIDRL) Full Time position - 80 hours per fortnight with monthly paid day off Fixed term to June 30 2027 Work on research within BSL-2, 3 and 4 facilities on high consequence pathogens in a world class research institute for the Cumming Global Centre for Pandemic...
-
Medical Scientist Grade 2
4 weeks ago
Parkville, Australia The Royal Melbourne Hospital Full timeMedical Scientist - Grade 2 Victorian Infectious Diseases Reference Laboratory (VIDRL) Full Time position - 80 hours per fortnight with monthly paid day off Fixed term to June 30 2027 Work on research within BSL-2, 3 and 4 facilities on high consequence pathogens in a world class research institute for the Cumming Global Centre for Pandemic...
-
Medical Scientist Grade 2
2 weeks ago
Parkville, Victoria, Australia The Royal Melbourne Hospital Full timeMedical Scientist - Grade 2 Victorian Infectious Diseases Reference Laboratory (VIDRL) Full Time position - 80 hours per fortnight with monthly paid day off Fixed term to June Work on research within BSL-2, 3 and 4 facilities on high consequence pathogens in a world class research institute for the Cumming Global Centre for Pandemic Therapeutics...
-
Engineering Safety Coordinator
1 month ago
Parkville, Australia 3065 CSL Innovation Full timeThe Opportunity:CSL has an exciting opportunity available for an Engineering Safety Coordinator to join the Building Operations & Services team and support the CSL R&D facility located at our state-of-the-art facility in Melbourne.Reporting to the Technical Services Lead – Building Operations and Services CSLM, the Engineering Safety Coordinator will...
-
Engineering Safety Coordinator
2 weeks ago
Parkville, Victoria, Australia 3065 CSL Innovation Full timeThe Opportunity:CSL has an exciting opportunity available for an Engineering Safety Coordinator to join the Building Operations & Services team and support the CSL R&D facility located at our state-of-the-art facility in Melbourne.Reporting to the Technical Services Lead – Building Operations and Services CSLM, the Engineering Safety Coordinator will...
-
Medical Scientist Grade 2
1 month ago
Parkville, Australia The Royal Melbourne Hospital Full timeMedical Scientist - Grade 2Victorian Infectious Diseases Reference Laboratory (VIDRL) Full Time position - 80 hours per fortnight with monthly paid day off Fixed term to June 30 2027 Work on research within BSL-2, 3 and 4 facilities on high consequence pathogens in a world class research institute for the Cumming Global Centre for Pandemic Therapeutics ...
-
Medical Scientist Grade 2
4 weeks ago
Parkville, Australia The Royal Melbourne Hospital Full timeMedical Scientist - Grade 2Victorian Infectious Diseases Reference Laboratory (VIDRL) Full Time position - 80 hours per fortnight with monthly paid day off Fixed term to June 30 2027 Work on research within BSL-2, 3 and 4 facilities on high consequence pathogens in a world class research institute for the Cumming Global Centre for Pandemic Therapeutics ...
-
Associate Scientist
3 weeks ago
Parkville, Australia CSL Behring Full time**The Opportunity** We have this excellent opportunity for an **Associate Scientist II** to join our Formulation Development team at CSL Innovation. The formulation team is part of the Biopharmaceutical Product Development (BPD) group of CSL Innovation R&D which focuses on delivery of new biotherapies to treat serious medical conditions. Based at our site...
-
Senior Advisor, Global Learning
2 weeks ago
Parkville, Victoria, Australia University of Melbourne Full timeAbout the RoleAs a Senior Adviser, you will play a key role in supporting the University's international programs, focusing on outbound exchange programs, study abroad programs, and inbound exchange programs.Lead initiatives to enhance program access for all student cohorts.Manage a portfolio of partnerships and programs to develop students' professional and...
-
Global Pv Compliance
2 weeks ago
Parkville, Victoria, Australia CSL Behring Full timeThe OpportunityWe have an exciting opportunity for a Global Pharmacovigilance Compliance and PV Intelligence Manager. This role is primarily responsible for active monitoring, implementation, maintenance and continuous improvement of the global PV system compliance management, vendor compliance oversight, end-to-end PV intelligence oversight and inspection...
-
Engineering Safety Coordinator
1 month ago
Parkville, Australia CSL Full timeThe Opportunity: CSL has an exciting opportunity available for an Engineering Safety Coordinator to join the Building Operations & Services team and support the CSL R&D facility located at our state-of-the-art facility in Melbourne. Reporting to the Technical Services Lead – Building Operations and Services CSLM, the Engineering Safety Coordinator...
-
Engineering Safety Coordinator
2 weeks ago
Parkville, Victoria, Australia CSL Full timeThe Opportunity: CSL has an exciting opportunity available for an Engineering Safety Coordinator to join the Building Operations & Services team and support the CSL R&D facility located at our state-of-the-art facility in Melbourne. Reporting to the Technical Services Lead – Building Operations and Services CSLM, the Engineering Safety Coordinator...
-
Senior Advisor, Global Learning
1 month ago
Parkville, Australia University of Melbourne Full timeAbout the Role As Senior Adviser you will support the delivery of the University’s overseas programs with a cross-program focus on semester/year-long outbound exchange programs, short-term exchange and study abroad programs, and inbound study abroad and exchange programs. You will play a lead role in delivering initiatives and programs at scale and...
-
Research Assistant in Immunology and Virology
3 weeks ago
Parkville, Australia University of Melbourne Full time**Job no**: 0061619 **Location**:Parkville **Role type**:Full-time; Fixed-term for 12 months **Faculty**:Medicine, Dentistry and Health Sciences **Department/School**:Department of Microbiology and Immunology, School of Biomedical Sciences **Salary**:Level A - $80,258 - $108,906 p.a. plus 17% super - **Conduct groundbreaking immunology research in immunology...