Principal Scientist, Device and Product Performance

at  Viatris

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 portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here’s how Principal Scientist, Device and Product Performance an SME role in Global Device Development, will make an impact:

Key responsibilities for 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 development by 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 activities for external and internal audits and inspections as applicable.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Degree in Science/Engineering (Master’s preferred)
• 7+ years’ 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 are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
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.
Viatris is an Equal Opportunity Employer.

Key responsibilities for 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 development by 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 activities for external and internal audits and inspections as applicable

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Degree in Science/Engineering (Master’s preferred)
• 7+ years’ 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