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7 hours ago
The role is responsible for delivering access to high quality, safe, robust and effective device and combination products to meet evolving patient healthcare needs. This involves developing device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products.
A key aspect of the job is working across Viatris to support innovative technology solutions that provide healthcare solutions for patients. The team operates from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA.
The ideal candidate will have a degree in Science/Engineering, preferably at Master's level, and proven experience in pharmaceutical and/or medical device development. Knowledge of design control requirements, such as FDA 21 CFR part 820 and ISO 13485, would be an advantage.
Key responsibilities include:
- Providing 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.
Benefits of this role include 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. Career progression opportunities and work-life balance initiatives are also available.
The role requires a 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 are essential for leading or facilitating effective discussions and communicating technical and/or project information to key stakeholders.
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