The Stability Associate is responsible for executing day-to-day activities to support stability study lifecycle s. This role requires a basic understanding of stability principles and has the ability to work well independently but under instruction and guidance of the line manager. The position focuses on preparing routine protocols, compiling data, basic statistical analysis, and escalating issues promptly.
Main Responsibilities and Accountabilities
1 Support a variety of tasks associated with ongoing stability programs :
* Able to prepare routine stability protocols and compiling data throughout study, keeping data tables up to date.
* Understand different trends associated with the data highlighting to senio r members of the team.
* Perform basic statistical analysis to support data interpretation and decision-making.
* Be aware of pull dates and associated testing, and which laboratories are responsible for conduct ing the different test methods.
* Maintain compliance with GMP, ICH guidelines, and internal procedures.
* Support investigations into stability-related deviations under guidance.
* Familiarity with electronic systems ( e.g. LIMS, JMP ) for data management.
2 Provid e knowledge and understanding :
* Basic understanding of stability principles and regulatory expectations.
* General a wareness of stability-indicating parameters and expected product profiles.
* Ability to recognize unexpected results and escalate appropriately.
* Basic knowledge of risk-based assessments and change control processes.
3 Working collaboratively :
* Coordinate with QC Operations to monitor progress of stability samples.
* Ensure routine stability studies are set up correctly and data available at all timepoints.
* Collaborate well with colleagues to achieve stability program objectives.
* Work effectively, demonstrating initiative and accountability.
4 Competencies:
Attention to Detail : Ensures accuracy in data compilation and reporting.
Problem Recognition : Identifies issues and escalates promptly.
Collaboration and Teamwork : Communicates clearly, contributing to a cohesive team environment.
Learning Agility : Shows readiness to develop scientific and technical knowledge over time.
Position Qualifications and Experience Requirements :
Education Requirements
* Associate degree (Foundation degree HND/HNC or equivalent Level 5 vocational qualification in science related subject essential.
* Science degree ( e.g. Bachelor) in pharmacy, pharmaceutical technology, biology, chemistry or comparable education preferred.
Experience Required
* 2 + years’ experience in the pharmaceutical manufacturing industry with direct exposure to Stability program development and management preferred
* Basic understanding of product lifecycle management in a global biotech or pharmaceutical GMP environment
* Awareness of current regulations and guidelines of stability monitoring of biopharmaceutical products
3 Other Essential Knowledge
* Fluency in English in both writing and oral communications
Please note - there are 3 positions available for this requisition
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
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