Overview
Downstream MS&T Scientist — Ireland, Dublin, 12 Month Contract.
This role is based at a large-scale facility in Dublin and involves working within a fast-paced project environment.
What you'll do
Identify and implement process improvements, e.g., yield and cycle time reduction, through evaluation of process performance using data analytics tools.
Provide process subject matter expertise for regulatory inspections and interactions with regulatory agencies (e.g., health authority query support, timely responses and data gathering), representing the Cruiserath site.
Provide on-the-floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolutions.
Identify or support process improvements (through change control or CAPA) and participate in the implementation of Lean initiatives at the site.
What you'll need
Minimum BSc or equivalent with at least 5 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry.
Demonstrated awareness of cGMP compliance and regulatory agency requirements, plus strong oral communication and technical writing skills.
Good interpersonal skills with the ability to work effectively in a cross-functional global environment, matrix organisation, and in local group settings.
Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
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