Senior Scientist/Engineer, 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
As a Senior Scientist/Engineer on the Device and Product Performance (DPP) team, you’ll be responsible for the testing of combination products within the Global Device Development (GDD) portfolio, which includes the generation of protocols, oversight of execution of testing at external test facilities and the writing of reports. You’ll also be involved in the execution of Design Verification activities within GDD programmes in support of design control activities while driving the strategic development of the DPP team process.

Every day, we rise to the challenge to make a difference and here’s how the Senior Scientist/Engineer, Device and Product Performance role will make an impact:

• Provide technical expertise to support the development of injectable combination products.
• Provide technical mentorship to more junior members of the injectables team, including guidance for technical issues and review/approval of documents.
• Lead the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites for programmes in the GDD portfolio in line with relevant guidelines and standards.
• Deal with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed, such as manufacturing investigations.
• Provide technical expertise to support the development of combination products.
• Lead and provide technical support to a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport and shipping studies.
• Trending and statistical analysis of analytical data including the compilation of technical reports to support combination product development lifecycle.
• Ensure that the combination product meets all requirements for reliability through the implementation of appropriate controls and assessment of the product against suitable specifications.
• Responsible for the compilation and review of technical documentation within GDD in line with global regulatory requirements, guidelines and the latest regulatory and industry thinking.
• Lead and review device investigations and participate in GDD and technical investigation teams as required.

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).
• 4+ years of experience in pharmaceutical and/or medical device development.
• Previous experience of working in R&D or Technical Services groups.
• Previous experience in managing activities with external test facilities, including test method development, validation and transfer.
• Experience in the development and validation of analytical methods.
• Experienced in the application of statistical techniques for data analysis.
• Previous experience working with pre-filled syringes, pen injectors or auto-injectors.
• Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.
• Previous experience in technical writing to support regulatory communications, including submissions and information requests etc.
• Demonstrable success in the alignment of Device/Combination Product development programs with, at a minimum, the US FDA requirements for Combination Product / Medical Device (preferably also other territories).

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.

Every day, we rise to the challenge to make a difference and here’s how the Senior Scientist/Engineer, Device and Product Performance role will make an impact:

• Provide technical expertise to support the development of injectable combination products.
• Provide technical mentorship to more junior members of the injectables team, including guidance for technical issues and review/approval of documents.
• Lead the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites for programmes in the GDD portfolio in line with relevant guidelines and standards.
• Deal with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed, such as manufacturing investigations.
• Provide technical expertise to support the development of combination products.
• Lead and provide technical support to a team responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport and shipping studies.
• Trending and statistical analysis of analytical data including the compilation of technical reports to support combination product development lifecycle.
• Ensure that the combination product meets all requirements for reliability through the implementation of appropriate controls and assessment of the product against suitable specifications.
• Responsible for the compilation and review of technical documentation within GDD in line with global regulatory requirements, guidelines and the latest regulatory and industry thinking.
• Lead and review device investigations and participate in GDD and technical investigation teams as required

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).
• 4+ years of experience in pharmaceutical and/or medical device development.
• Previous experience of working in R&D or Technical Services groups.
• Previous experience in managing activities with external test facilities, including test method development, validation and transfer.
• Experience in the development and validation of analytical methods.
• Experienced in the application of statistical techniques for data analysis.
• Previous experience working with pre-filled syringes, pen injectors or auto-injectors.
• Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.
• Previous experience in technical writing to support regulatory communications, including submissions and information requests etc.
• Demonstrable success in the alignment of Device/Combination Product development programs with, at a minimum, the US FDA requirements for Combination Product / Medical Device (preferably also other territories)