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Lead the development of combination product methods in the R&D laboratory and provide technical mentorship to junior team members. Responsible for design verification, method validation, and the compilation of technical documentation for global regulatory compliance.
Requires a Master's or Bachelor's degree in Engineering or Science with at least 2 years of laboratory experience. Proficiency in statistical techniques and knowledge of GMP and design control requirements (FDA/ISO) is highly advantageous.
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
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
Lead the development of combination Product methods R&D Laboratory whilst providing technical mentorship to more junior members of the team, including guidance for technical issues and review/approval of documents as well as support for the lab manager.
Every day, we rise to the challenge to make a difference and here’s how the Device and Product Performance Scientist role will make an impact:
Provision of technical laboratory expertise to support the development of Combination Products.
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 & shipping studies.
Provide technical mentorship to more junior members of the team, including guidance for technical issues and review/approval of documents.
Leading the Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
Dealing 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.
Responsible for testing of combination products within the Global Device Development portfolio including generation of protocols, oversight of execution of testing at external test facilities and writing of reports.
Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.
Lead and review device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™.
Support of all R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.
Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Experience in the development and validation of analytical methods is an advantage.
Experienced in application of statistical techniques for data analysis.
Masters/Degree in Engineering/Science with minimum 2 years’ experience in a lab environment.
Previous experience using in a regulated GMP environment would be an advantage
Working proficiency with Minitab 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.
Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
Some travel may 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. 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
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
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.
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Viatris is a global healthcare company empowering people worldwide to live healthier at every stage of life.
Offices: Pittsburgh, US · Krijgsman 20, Amstelveen, North Holland 1186DM, NL · Terhulpsesteenweg 6a, Hoeilaart, Flemish Region 1560, BE
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