Downstream Scientist (Manufacturing Technology) – 12 Month Contract
We are seeking an experienced
Downstream Scientist (Manufacturing Technology)
to join a high-performing biopharmaceutical manufacturing environment on a
12-month contract
.
This role plays a critical part in providing process validation support and ongoing technical oversight for commercial drug substance manufacturing operations.
You will work within a highly collaborative, cross-functional setting, partnering closely with Manufacturing, Engineering, Quality, and Regulatory teams to ensure robust, compliant, and efficient downstream processes.
Key Responsibilities
Provide technical expertise and support for
downstream drug substance manufacturing processes
, including:
Buffer preparation
Purification and viral reduction steps
Chromatography operations
Ultrafiltration, viral filtration and viral inactivation technologies
Drug substance formulation and bulk fill
Develop a strong scientific understanding of the molecule and its associated manufacturing process.
Author and review
technical documentation
Lead and execute
technical and plant-supporting studies
at commercial scale.
Identify and implement
process improvements
(e.g. yield optimisation, cycle time reduction) using data-driven analysis.
Provide
on-the-floor technical support
, including troubleshooting manufacturing issues and leading investigations into process deviations.
Act as
process SME
during regulatory inspections and technical interactions with regulatory agencies.
Communicate learnings and outcomes through internal forums and, where appropriate, external scientific meetings.
Support continuous improvement initiatives through
change control, CAPAs, and Lean programs
.
Qualifications & Experience
BSc or equivalent
in a scientific discipline.
Minimum 2 years' experience
in drug substance manufacturing technical support within the biopharmaceutical industry.
Strong knowledge of
cGMP requirements
and regulatory expectations.
Proven technical writing and documentation skills.
Excellent interpersonal and communication skills, with the ability to work effectively in
cross-functional and matrix environments
.
Ability to present, defend, and influence technical decisions while balancing product quality and operational needs.
Comfortable operating without direct line authority and influencing key stakeholders.
Additional Information
This is an
on-site role
based in Dublin, Ireland.
The position may
occasionally require extended hours or on-call support
to meet manufacturing needs.
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