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 :
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.
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.