Job Description
Operations Lead for a new regenerative medicine facility to be built at TIL Grange Castle.Leads the technology transfer of the introduction of the product Alofisel designated for P3 manufacturing site at TILGC.Supports operational readiness for Alofisel aseptic manufacturing and filling at new P3 facility at TILGC.Provides technical support for all manufacturing activities associated with the P3 facility at TILGC.SME for aseptic processing of regenerative medicine in compliance with GMP and relevant regulatory requirements.As part of Operational Readiness lead the AlofiselTechnology TransferScope includes regenerative medicine manufacturingDelegate tasks and communicate priorities to team membersDevelop and own the Alofisel Tech Transfer ScheduleLiaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshootingUnderstand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.Lead the process validation.Provide direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and in compliance with Quality standards.Support P3 operations team with achieving overall operational readiness schedule adherence.Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.Complete required documentation relating to technology transfer, development and manufacturing activities for Alofisel in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.As part of production operations:
Lead and manage production operations (aseptic manufacturing, filling and packaging) and production related warehousing & logistics within the bioprocessing plant.Manage escalation, decision making and communication within production team.Driving compliance and schedule adherence to ensure the operational plan is achieved, including close out of all documentation.Manufacturing subject matter expert representing the manufacturing department in internal, global and regulatory audits and maintain an audit ready mind-set in manufacturing areas.Maintain and develop quality standards to cGMP guidelines; operations lead in regulatory and customer audits (e.g. HPRA audits, Sterility Assurance, Environmental Health & Safety)Take ownership of environmental performance in the manufacturing area and work continuously to ensure the strongest environmental performance possible by proactively and constantly improving control strategies and employee engagement in this area.Lead and support investigations in manufacturing and technical deviations.Facilitate training and development of all production, warehousing personnel of the Bioprocessing Plant, ensuring they have the skills and knowledge to carry out their duties efficiently and safely and according to cGMP standards.Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
https://www.takedajobs.com/location/ireland-jobs/1113/2963597/2
Job ID R0021352Date posted 07/10/2020Location Dublin, IrelandBy...
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