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Principal Scientist

Posted 11 hours 51 minutes ago by Quanta Consultancy Services Ltd

Permanent
Full Time
Other
Dublin, Dublin, Ireland
Job Description
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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