Cache of job #13816880

Job Title

Process Scientist

Employer

CPL

Location

Grange Castle, Dublin West

Description

Process Scientist. Role Description. General Information: Job Title: Process Scientist. Department: Grange Castle Technical Operations. Position Reports to: Senior Process Scientist – Technical Operations DS. Introduction. Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant is situated on a 90-acre site in South Dublin. The site manufactures Biopharmaceuticals and Vaccines – with multiple manufacturing technologies, including; large-scale mammalian cell culture, protein purification, vaccines conjugation, and aseptic syringe filling. This role will be to provide process science support to the ongoing requirements of the Drug Substance Operating Unit. The process scientist is responsible for ensuring that the process is running as intended and that all technical issues are resolved to support the technical transfer and validation of new products and the manufacture and timely disposition of existing products within the Drug Substance Operating Unit. Responsibilities. 1. Provide routine process technical support, trouble-shooting and resolution of manufacturing process and technology issues to ensure the successful completion and disposition of batches in a timely manner. 2. Experience writing technical documents, including SOPs, batch records that describe protein manufacturing unit operations and processes. 3. Deliver presentations that distil complex ideas and proactively communicate results and progress to technical teams, management, and business leadership. 4. Troubleshoot issues arising through the Investigation (ER / QAR) process including but not limited to leading technical investigations and supporting the implementation of immediate CAPAs. 5. Perform real time Process Monitoring and data collation to support problem definitions, and development of remediation plans. 6. Be competent with Quality Systems, including Manufacturing Investigations, Change Controls and Commitments and Maintenance systems. 7. Work to implement a culture of Right-First Time through partnerships with Operations and Core Engineering and Core Technical Services to optimise our technical and business processes. Experienced Required. Experience in mammalian cell culture or protein purification, working in a cell culture-based manufacturing or process development environment. Experience in downstream process development and scale-up for biopharmaceutical protein production would be advantageous. Experience with shake-flask culture, bioreactor operation, aseptic technique, and mammalian cell culture. Working knowledge of Harvest/Cell Clarification. A minimum of 5 Years cGMP industrial experience. 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./Men. 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 more information, contact me, Amina Tutunova, on Amina.Tutunova@cpl.ieor 01 614 6161. This job originally appeared on RecruitIreland.com.

Date Added

2354 days ago

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