Stability Scientist

The Opportunity
CSL Behring is looking for a Stability Scientist to join our team on a permanent full-time basis at our Broadmeadows site.
Reporting to the Stability Lead, you will be responsible for planning, developing, and executing stability activities associated with both projects and routine stability activities, for product as allocated, ensuring activities are implemented to industry and regulatory requirements for CSL Behring Australia.
The Role

• Scheduling of stability trials
  
• Preparation of protocols
  
• Data review and trend evaluation, inclusive of Out of acceptance (OOx) criterion result investigation (OOX = Out of Specification, Out of trend or Unexpected Results)
  
• Preparation of all reports in accordance with agreed timelines, as per local/global and regulatory requirements
  
• Participation in internal and external audits and support the completion of associated inspection finding tasks, as required
  
• Prepare, review, implement and maintain departmental documentation for stability activities (i.e. SOPs, work instructions and forms etc.)
  
• Work collaboratively with stakeholders including but not limited to, Manufacturing, Regulatory Affairs, Quality Control, Quality Assurance, CoE on stability topics and other Behring sites, to ensure stability activities are planned and delivered in an efficient timeframe
  
• Investigate and provide support as required for stability related deviations
  

Your skills and experience

• A relevant science or engineering tertiary qualification.
  
• 1-2 years of experience in stability
  
• Experience in pharmaceutical manufacturing, quality or operations in a cGMP environment.
  
• Experience using Microsoft applications and in particular statistical analysis software
  
• Experience in statistical trend analysis
  
• Sound knowledge of cGMP and industry guidance documents and standards, with a good understanding of stability principles
  
• Stakeholder relationship and management
  

How to apply
Please submit your application including your resume by 15th February 2024 .
Apply now to join a growing business in a great team environment.
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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 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.
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 Behring!