Tech Transfer Process Scientist

COLLINS MCNICHOLAS RECRUITMENT

DUBLIN SOUTH

Tech Transfer Process Scientist: An Experienced Process Scientist with relevant experience is required to join a leading Biopharmaceutical company. This Process scientist will become a keymember of the transfer team, working within the site Technical Services supporting the multiple transfer of the mammalian cell culture processes (Upstream and Downstream. Role Responsibilities: Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up. Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment. Execute requisite process trials to facilitate transfer as required (bioreactor kLa studies, media/buffer make-up & hold, cleaning cycle development, column packing, preservative flush-out, media simulations, etc. Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables. 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. 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. Role Requirements: Experience working in a cell culture manufacturing process or process development environment. Familiarity with the operation of cell culture and/or purification technology. Experience of process and cleaning validation requirements and execution for GMP biological production. Knowledge of technology transfer is preferred but not a requirement. Demonstrated aptitude for technical learning and problem-solving. Strong evidence of problem-solving skills. Good communication skillsA minimum of a BSc., B.E. or MSc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or. Industrial Chemistry Degree with a large element of engineering fundamentals as applied to biotechnology in the curricular. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1618 days ago