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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit
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