Description
A global pharmaceutical company are seeking a Senior Inhalations Scientist to join their QC team in there brand new plant in Dublin. It's an exciting opportunity to work in a greenfield site in a state of the art facility on a very exciting new project.As part of the R+D team you will be the manager responsible for late stage process development, and the coordination of development activities to support the regulatory filing of new inhalation drug products.
The Senior Inhalations Scientist Role will involve:
- Formulation development, process development.
- Product and analytical transfer for Dry Powder Inhaler (DPI) products. - Process development/scale-up for respiratory products.
- Successful development and transfer of the commercial manufacturing process, analytical methods and product knowledge.
- Design and execute experimental studies using QbD principles to nominate formulations, and generate supporting data for regulatory filing.
- Through statistical analysis, measure, control and improve on product and process robustness throughout product life cycle.
- Identify process unit operation parameters and perform scale up / transfer trials from R+D to commercial operations.
- Adhere to overall project plan, prioritizing project deliverables and resource allocation to ensure on time delivery of project milestones.
- Author, and coordinate the completion of, elements of the product submission files.
Requirements:
- Qualified / experienced inhalations professional.
- Minimum of a degree in Pharmacy / Chemistry.
- 5 + years relevant experience in inhalation product development / manufacture required.
- Proficiency in statistical software packages and MS Project.
- Strong understanding of Formulation and Process Development, and Analytical testing of an inhalation product.
- Previous experience with the technology transfer of complex drug product / medical devices and / or respiratory required.
- A good understanding of the requirements of Good Manufacturing Practices (GMP) and Quality systems.
This is a permanent position, a excellent salary and benefits is on offer. If you feel you are good fit for this role please apply below with an up to date CV. Or contact me Aaron Thong