Senior Scientist

We are currenting hiring aSenior Scientist/ Engineer, Device and Product Performance for a Dublin based Life Science Client


Key responsibilities for this role include:

• Provision of technical expertise to support the development of Injectable Combination Products.
• Providing technical mentorship to more junior members of the injectables 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 external test facilities or manufacturing sites.
• Execution within internal laboratories, and/or coordination of product characterization and engineering verification testing, method development and validation to support robust product understanding throughout device development.
• Dealing with the client 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 pre-filled syringes, pen injectors and potentially other devices within the Global Device Development portfolio (for example, Auto-Injectors), 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™.
• Responsible for following all EHS process and procedures.

• Minimum of Bachelor’s degree in Science /Engineering with a minimum of 4 years experience of working with drug products and devices in R&D or Technical Services groups.
• Minimum of 2 years experience in working within a laboratory environment, including experience in Method Development and Validation within Combination Products.
• Previous experience in supervision activities with external test facilities, including test method development, validation and transfer.
• Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
• Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.
• Willingness to learn and open to alternative ideas and solutions. Well-developed communication skills to lead or facilitate effective discussions with key stakeholders.
• Some travel will be required as part of this roles