Principal Scientist

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.