Principal Scientist / Engineer, Device and Product Performance

McDermott Laboratories Limited

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, biosimilar 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 Scientist / Engineer (Device and Product Performance), an SME role in Global Device Development , will make an impact :

Key responsibilitiesfor this role include :

Provision of subject matter expertise to support the development of Combination Products

Leading a team to plan and execute design verification and reliability strategies.

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 evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable.

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 developmentby providing device controls and sampling plans.

Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification,and reliability.

Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.

Lead support activitiesfor external and internal audits and inspections as applicable.

The minimum qualifications for this role are :

Degree in Science / Engineering (Master’s preferred)

Proven experience in pharmaceutical and / or medical device development

Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage

Experience in the development and validation of analytical methods

Experienced in application of statistical techniques for data analysis

Experience of writing and supporting regulatory submissions

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 andan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.