The Stability Senior Scientist provides more advanced technical expertise in stability science than the Stability Scientist, owning more complex activities and supporting junior scientists. This integral in ensuring a robust stability program, supports regulatory requests, and delivers continuous improvement activities within a global team environment. The position also focuses on preparing protocols, compiling data, identifying trends, performing statistical analysis, generating stability reports and escalating issues promptly.

Role that this position reports to:

Stability Lead (Product specific)

· Positions report into this role:

None

· This position can be delegated to:

Stability Scientist

Main Responsibilities and Accountabilities

1

Conducting a variety of tasks associated with ongoing stability programs:

• Expertise in preparing protocols, compiling data, and generating detailed stability reports.

• Lead compilation, interpretation, and presentation of stability data.

• Perform advanced 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 Principal Stability Scientist.

• Lead investigations into stability-related deviations and propose corrective actions.

• Ensure compliance with GMP, ICH guidelines, and internal standards.

• Skilled in using electronic systems (LIMS, Statistica) for data management.

Providing 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

• Good knowledge of 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 without constant supervision, demonstrating initiative and accountability

• Ability to support multiple projects and deliver objectives on time.

Education

• Science degree (e.g. Bachelor, Master, PhD) in pharmacy, pharmaceutical technology, biology, chemistry or comparable education.

Experience Required

• 3+ years’ experience in the pharmaceutical manufacturing industry with direct exposure to Stability program development and management

• Good technical understanding of product lifecycle management in a global biotech or pharmaceutical GMP environment

• Good grasp of current regulations and guidelines of stability monitoring of biopharmaceutical products

Other Essential Knowledge

• Fluency in English in both writing and oral communications

Competencies:

Knowledge/skill sharing: Provides training and technical guidance to junior scientists.

Strategic Thinking: Aligns stability activities with departmental objectives.

Analytical Skills: Applies advanced statistical methods for decision-making.

Impact and Engagement: Supports regulatory requests and cross-functional collaboration

Self-Management: Operates effectively with minimal supervision in a global environment.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.