- Reference: CJ45825
- Job Type: Contract
- Location: Dublin North, Dublin South, Dublin West
- Category: Science, Pharmaceutical & Food
- Key member of the transfer team, working within Technical Services, supporting the transfer of the mammalian cell culture processes (Upstream and Downstream).
- Provide process science and manufacturing technology support for the technology transfer of a cell culture-based process into an existing facility, including representing site at key internal and external tech transfer meetings.
- Provide independent decision making for strategic input into facility fit assessment and equipment design.
- Capture all aspects of the existing process and equipment to ensure an equivalent process is transferred to the site, including technology transfer of upstream or downstream unit operations, including Gap Analysis and Process Transfer Risk Assessment
- Support facility fit assessment for the site transfer.
- Support introduction of new materials required for the project.
- Execute requisite process trials to facilitate transfer as required (medium or buffer make-up & hold, resin and membrane lifetime studies, etc)
- Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables
- Ensure the process automation meets the requirements of the process, including providing process input to equipment and instrumentation ranges.
- Execute water, demonstration and GMP batches
- Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to the site.
- Lead major process investigations as requested and support the implementation of CAPAs.
- Provide technical training on process and technology areas as required by the project.
- Strong experience in mammalian cell culture or protein purification, working in a cell culture-based manufacturing or process development environment.
- Familiarity with the operation of cell culture (upstream or downstream) technology
- Experience in technology transfer and/or facility fit assessment
- Demonstrated aptitude for technical learning.
- Strong evidence of problem solving skills
- Good communication skills
- A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with a large element of biotechnology in the curricular.
For a confidential discussion and more information on the role, please contact Laura Jevens on 021 4911060 or email firstname.lastname@example.org
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