- Reference: GY44623
- Job Type: Permanent
- Location: Galway
- Category: Science, Pharmaceutical & Food
The R&D Senior Formulation Scientist will be responsible for leading and executing development activities for progression of injectable products from concept to successful launch. This involves design and execution of experimental studies that will define stable formulations and suitable packaging for injectable products (Solution, Lyophiles and suspensions). Design and perform studies that identify a small scale process. Lead scale up and technical transfer activities of a robust manufacturing process to a GMP production site. Provide clear interpretation and presentation of data to support technical decisions/recommendations. Write reports for use in regulatory submissions and preparation of GMP documentation
- Requires a high level of scientific knowledge and expertise in product and formulation development.
- Understand properties of the drug that influence formulation design studies.
- Degradation mechanisms and developing control strategies to minimize these.
- Selection of primary packaging (packaging compatibility, L&E studies, container closure integrity).
- Material compatibility with product.
- Principles of process development and scale up for manufacture.
- Fundamentals of statistical data analysis.
- Knowledge of Quality systems, GMP and GLP requirements for pharmaceutical development.
Skills, Experience and Qualifications:
- Process scientist/engineer/formulator with a good working background in biopharmaceutical processing.
- Prior experience in combination device space, namely cartridge/Prefilled filled syringe filling would be desirable.
Great work ethic and a “can-do” attitude. Good communicator.
Organised. Self-confident and desire to succeed.
Candidate would need to use his/her own initiative and be self-driven.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org