Principal Scientist (Downstream)
Location: Dublin, Ireland.
Contract: 12-Month.
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 other interactions with regulatory agencies (e.g., health authority query support – timely responses, data gathering, etc.), representing the Cruiserath site.
Provide on-floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolution.
Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.
What you'll need:
Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry.
Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
Good interpersonal skills coupled with demonstrated ability to effectively work 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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