At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via :
- Access – Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
Our Global Device Development is an innovative, technically-excellent and fully integrated organization, delivering access to high quality, safe, robust and effective device and combination products to meet the worlds’ evolving patient healthcare needs. We develop device technologies to enable drug-delivery for respiratory, biologic and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
Every day, we rise to the challenge to make a difference and here’s how the Principal Respiratory Scientist role will make an impact.
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 moulding 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.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.