Process Scientist Tech Transfer - Pfizer
Cpl in partnership with our client Pfizer are currently recruiting for a Senior Process Scientist - Tech Transfer based in their Grange Castle Site. This is an exciting opportunity to join the Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant which is situated on a 90-acre site in South Dublin. Grange Castle's state of the art technology & production expertise results in the production of quality-driven products that improve people's lives around the world. Role Description: We are seeking a Senior Process Scientist, whose role will be: Job Responsibilities: Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle. Knowledge of downstream (unit operations including chromatography, filtration and UFDF) or upstream unit operations. Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables. Execute requisite process trials to facilitate transfer as required (buffer make-up & hold, resin and membrane lifetime studies, etc. Develop process validation protocols and lead their execution on the floor in conjunction with Operations. Generate process validation summary reports and associated filing summaries. Ensure the process automation meets the requirements of the process. Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges. Execute water, demonstration and process validation batches. Drafting of filing submissions and assist with inspection readiness activities including preparation of playbooks. Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC. 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. Experience: Experience working in a cell culture manufacturing process or process development environment. Familiarity with the operation of cell culture (upstream or downstream) technology. Knowledge of technology transfer process and requirements. Demonstrated aptitude for technical learning. Strong evidence of problem solving skills. Good communication skills. Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we behave, act, lead and engage with people every day. Our vision is, together, deliver life changing medicines to our patients. Our success is achieved through the commitment, engagement and excellence of all our colleagues. Education: A minimum of aB.Sc., B.E. orM.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. This is an 11 month contract. To apply or for more infomration contact Libby Ryan on 01 947 6269 or firstname.lastname@example.org. This job originally appeared on RecruitIreland.com.
105 days ago