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Details
Senior Scientist
Reference: | RH/A008940 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Permanent | Salary: | €45000 - €50000 |
May be suitable for:
Senior Scientist, 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
Any applicant must have an existing work visa/ permit or EU passport to apply.
Call Ruth Holland on 087-7822 198 for more information.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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