Job Descriptions

Key responsibilities for this role include:

• 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 minimum qualifications for this role are:

• Degree in Science/Engineering
• 5+ years experience in pharmaceutical and/or medical device development with experience in respiratory product development
• Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485
• 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

Skills

• Communication Skills
• Management Skills

Experience

• 5+ years