Senior Scientist, Device & Product Performance Locations: Northern Cross, Dublin, Ireland
Time Type: Temps plein
Posted On: Offre publiée hier
Job Requisition ID: R5646601
McDermott Laboratories Limited
Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie.
The Role & What You Will Be Doing Execute Design Verification activities within GDD programs in support of design control activities. Drive strategic development of Device and Product Performance (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:
Provision of technical expertise to support the development of injectable combination products. Provision of technical mentorship to more junior members of the injectables team, including provision of 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 for programs in the GDD portfolio in line with relevant guidelines and standards. 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. Provision of 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 & shipping studies. Provide technical mentorship to more junior members of the team, including guidance for technical issues and review/approval of documents. 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. About Your Skills & Experience Degree in Science/Engineering (Master's preferred) and 4+ years 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 application of statistical techniques for data analysis. Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks. Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders. Ability to travel will be required as part of this role. Benefits at Viatris 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.
Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission.
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