R&D Senior Scientist Virus Validation
Job Type: Full time
We have an exciting opportunity available for an experienced R&D Senior Scientist Virus Validation to join the Global Pathogen Safety (GPS) team at our Broadmeadows site at CSL Behring. Reporting to the Senior Manager, Virus Validation (AUS) you will lead a team of scientists responsible for the development and validation of new virus reduction processes using scale down models of plasma, recombinant, cell and gene therapy and vaccines manufacturing processes. You will also manage the team to undertake studies to support CSL's existing products. You will apply the principle of pathogen safety by design (PSbD), work in close collaboration with external partners within CSL to develop new processes or improve current processes.
You will be the subject matter expert and work with the outsourcing lead to ensure studies are conducted to CSL standards. You will serve as a Study Director for studies required to be conducted to GLP standards and have in-depth knowledge of process sciences.
Due to the global nature of this position, you will, from time to time, participate and present in global technical forums and support any work required from other sites.
- Lead a team that can generate scientifically sound laboratory-based studies with a focus on evaluating, developing, qualifying, and validating virus reduction steps in manufacturing processes of CSL plasma-derived, recombinant, vaccines and cell and gene therapy products
- Seek new approaches and develop work packages according to the principles of PSbD in close collaboration with other pillars such as process development and bioanalytical sciences to develop processes that generates safe and efficacious products for our patients
- As the Study Director, lead studies conducted following the OECD Principles of GLP to ensure there is full agreement of the study protocols and final reports with relevant partners and to internal CSL standards and expectations.
- In close collaboration within GPS support pillar, summarise, present, and discusses respective pathogen safety studies, concepts, and methodologies of the company during both external and internal regulatory and quality audits.
- Identify opportunities and implement globalization/harmonization initiatives (focussing on laboratory-related objectives) across sites to lead internal efficiencies and establish best practice
Your skills and experience
- PhD, Masters or B.Sc. in Virology, Biochemistry, Biology, or related biological fields
- Minimal 4 years' of experience in a Biopharmaceutical R&D or academic setting. Experience in process virus reduction validation studies following OECD Principles of GLP would also be an advantage
- Experience with scale down modelling of manufacturing processes and working with pathogens (viruses, prions)
- External recognition as a scientific expert in the field of biological process pathogen safety or similar and a record of scientific publication and presentations at international scientific conferences
If you like to work for a values-based, purpose-driven company, apply now!
Please include a CV and Cover Letter in your application. Applications close 5pm AEST on 31st March 2023.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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