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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Principal Respiratory Scientist


Reference:JCO0414 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client a global healthcare company currently seeks a Principal Respiratory Scientist. The Principal Respiratory Scientist will act an SME role in a Global R&D Group :


Role/Responsibilities:

  • SME to support development of a bespoke respiratory device from program initiation up to regulatory submission.
  • Responsible for building product knowledge and understanding by assessing device functionality and combination product performance from early-stage device design.
  • Responsible for technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development.
  • Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
  • Responsible for developing test methods and specifications to assess device functionality and product performance including procurement and qualification of new laboratory equipment.
  • SME responsible for supporting metrology testing and defect analysis to support component molding process development and qualification.
  • Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification.
  • Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans.
  • Trending and statistical analysis of design verification and manufacturing data including compilation of technical reports to support combination product development lifecycle.
  • Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.



Skills/Experience:

  • The ideal candidate will be a qualified, experienced pharmaceutical professional with experience in respiratory product development.
  • Masters/Degree in Science with experience in research and development of respiratory products.
  • Previous experience of working as a Scientist role in a regulated and GMP environment.
  • Experienced in application of statistical techniques for data analysis.
  • Experience of writing and supporting regulatory submissions would be an advantage.
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role.
  • Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
  • Some travel will be required as part of this role.

For further information please contact James Cassidy [email protected] or call in confidence 086-0204322