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Job Title: Stability Scientist
Core Activities
- Expertise in setting up studies, preparing protocols, compiling data, and generating detailed stability reports
- Perform approvals of protocols and reports
- Lead compilation, interpretation, and presentation of stability data
- Perform statistical analysis and data extrapolation to support decision-making
- Train Stability Scientists in technical and knowledge-based aspects
- Support lower-level regulatory requests and provide necessary documentation
- Coordinate with QC Operations to ensure timely sample pulls, testing, and data entry into LIMS
- Conduct risk-based assessments in collaboration with the Principal Stability Scientist
- Lead and manage complex investigations into stability-related deviations and propose corrective actions
- Lead and manage multiple stability projects concurrently, ensuring alignment with business priorities and regulatory obligations
- Ensure compliance with GMP, ICH guidelines, and internal standards
- Skilled in using electronic systems (e.g., LIMS, JMP) for data management
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Knowledge and Understanding
- High level of understanding of regulatory requirements and stability principles
- Comprehensive knowledge of product stability profiles and key indicators
- Ability to lead investigations and provide technical guidance
- Good product knowledge and understanding of expected profiles
- Experienced in risk-based assessments and change control processes
Working Collaboratively
- Deliver global stability activities and ensure timely execution
- Coordinate with QC Operations to monitor progress of stability samples
- Proactively identify and resolve issues impacting stability programs
- Work effectively with limited supervision, demonstrating initiative and accountability, and providing support to teammates as necessary
- Ability to support multiple projects, directing team members to deliver goals and milestones on time
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers globally, CSL Seqirus prevents influenza worldwide and plays a key role in pandemic preparedness. With advanced production facilities in the U.S., the U.K., and Australia, the company uses egg, cell, and adjuvant technologies to distribute influenza vaccines in over 20 countries.
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Our Benefits
Discover how CSL supports your well-being
You Belong at CSL
At CSL, Inclusion and Belonging is central to our mission and culture. Our diverse workforce drives innovation through curiosity and empathy, helping us better understand patients, donors, and stakeholders.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. For accessibility accommodations during the application process, please visit:
Watch CSL Seqirus’ ‘On the Front Line’ video (link to video) to learn more about the work.
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