Cpl in partnership with our client Pfizer are seeking a Process Scientist - DS Vaccines to join the team for an 11 month fixed term contract in their state of the art plant in Dublin, Grange Castle. This role will be hybrid working.
This role will be to provide process science and/or engineering support to the ongoing requirements of the Vaccines Drug Substance Operating Unit. The process scientist is responsible for providing 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. The role requires flexibility to work within the projects technical transfer space and/or commercial technical services team.
We are seeking Process Scientists/Engineers whose role will be:
- Key member of the site technical services team, supporting the technology transfers and commercial manufacture of vaccines and representing the site at key internal and external meetings.
- Provide technical oversite of transfer activities and/or routine process monitoring and follow-up on any significant issues/trends
- Support technology Transfer activities including Gap Analysis, Process Transfer Risk Assessment, Process Description, Process design, Validation, etc.
- Support introduction of raw materials or consumables and assessment of Supplier Change Notifications (SCN)
- Ensure the process design meets the requirements of the process
- Input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges
- Liaise with site functions – 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 the implementation of CAPAs
- Provide technical training on process and technology areas as required by the project.
- Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.)
- Deliver presentations that distill complex ideas and proactively communicate results and progress to technical teams, management, and business leadership
- Be competent with Quality Systems, including Change Controls, Commitments and Maintenance systems
- Support Compliance Inspections and enquiries from Regulatory Agencies
Requirements:
- 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.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