Process Scientist - DS Vaccines
This is an 11 month fixed term contract role in our state of the art plant in Dublin, Grange Castle. The role will be hybrid working.
Key Responsibilities
* A key member of the site technical services team, supporting technology transfers and commercial manufacture of vaccines.
* Provide technical oversight of transfer activities and routine process monitoring.
* Support technology Transfer activities including Gap Analysis, Process Transfer Risk Assessment, and Process Description.
* Evaluate raw materials or consumables and assessment of Supplier Change Notifications (SCN).
* Ensure process design meets requirements.
* Liaise with logistics, planning, QA, QC, Operations, Regulatory Affairs to support routine processing and/or transfer activities.
* Develop process trial/validation protocols and lead their execution in conjunction with Operations.
* Generate process trial/validation summary reports and associated filing submissions.
* Lead major process investigations as requested, including preparation of process impact assessments and support implementation of CAPAs.
* Provide technical training on process and technology areas as required by the project.
* Deliver presentations that distill complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
Requirements
* Minimum of 2 – 5 years' experience in manufacturing process, process development, or tech transfer environment.
* Experience and knowledge of biological manufacturing processes, e.g., conjugation reactions, ultrafiltration/diafiltration, and drug substance filling.
* Knowledge of technical transfer.
* Demonstrated aptitude for technical learning and problem solving.
* Good communication skills (verbal, written).
* Experience of FDA and EU licensing desirable.