Process Scientist - DS Vaccines
We are seeking a skilled Process Scientist to join our team for an 11-month fixed-term contract in Dublin, Grange Castle. The role will be hybrid working.
The successful candidate will provide process science and engineering support to the ongoing requirements of the Vaccines Drug Substance Operating Unit.
Main Responsibilities:
1. Provide technical support to the operating unit ensuring that processes are transferred to site as required and that they are robust, appropriately validated, and run so as to maintain that validated state.
2. Support technology transfer activities including Gap Analysis, Process Transfer Risk Assessment, Process Description, Process design, Validation, etc.
3. Support introduction of raw materials or consumables and assessment of Supplier Change Notifications (SCN)
4. Ensure the process design meets the requirements of the process
5. Liaise with site functions logistics, planning, QA, QC, Operations, Regulatory Affairs to support routine processing and/or transfer activities
6. Develop process trial/validation protocols and lead their execution in conjunction with Operations
7. Generate process trial/validation summary reports and associated filing submissions
8. Lead major process investigations as requested, including preparation of process impact assessments and support the implementation of CAPAs
9. Provide technical training on process and technology areas as required by the project
10. Provide independent decision-making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.)
Requirements:
* A minimum of 2-5 years' experience working in a manufacturing process, process development, or tech transfer environment
* Experience and knowledge of biological manufacturing processes, E.reactions, ultrafiltration/diafiltration, and drug substance filling
* Demonstrated aptitude for technical learning and problem-solving
* Good communication skills (verbal, written)
* Experience of FDA and EU licensing desirable