Manager, laboratory and production, actris

1 week ago

Singapore Consortium For Clinical Research And Innovation Singapore Full time

Manager, Laboratory and Production, ACTRIS Overview The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore and establish important capabilities for a future-ready healthcare system. The Business Entities under CRIS include: Singapore Clinical Research Institute (SCRI) Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) Cardiovascular Disease National Collaborative Enterprise (CADENCE) Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you ACTRIS The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence to facilitate discovery, process development and manufacturing of cellular-based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients. What you will be working on Develop, plan and implement manufacturing operations and business processes for a new facility start-up. SOPs, workflows and processes shall be critically thought out to cater for cell therapy products and must be appropriate for clinical and commercial manufacturing. Assist in the preparation for all licensing and audit inspections for regulatory authorities as necessary. Oversee production of cell-based therapy products in clean rooms, which includes processing, product storage, shipments, sampling etc. Ensure products are manufactured in compliance to Regulatory, Good Manufacturing Practice (GMP) & Environmental Health and Safety (EHS) guidelines. Must be knowledgeable in aseptic operations and standard cell processing procedures such as tissue culture, cryopreservation etc. Timely review of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice). Champion safety and quality mindset. Manage all aspects of laboratory operations, which include planning production schedules, resolving operational issues and efficient allocation of manpower and resources. Manage equipment and clean rooms, which include timely maintenance, calibration, monitoring and repair. Manage production materials inventory, ahead of production processes. Plan and manage production schedules for multiple clean rooms. Responsible for production documentation and batch records. Participate in the development of new manufacturing processes, process improvement and risk assessment activities. Jointly lead and drive commissioning, qualification and validation activities for new facility. Perform or supervise process validation activity for incoming new projects. Review and/or author production related documents such as SOPs, batch records, protocols etc. Identify process gaps and opportunities for process improvement within the lab. Implement initiatives to streamline workflows and enhance overall lab operations. Identify potential risks, hazards or non-compliances issues and take appropriate measures to mitigate them. Support manufacturing-related change controls; as well as deviation investigations for non-conformance. Able to troubleshoot and conduct deviation investigations. Lead root cause analysis for complex issues and implementation of corrective or preventive actions. Handling compliance records such as deviation reports and change controls. Supervise and mentor laboratory officers, which include providing training, guidance and performance feedback. Actively and jointly participate in the preparation and management of department’s goals, project, budget, costing and other activities. Support new product introduction and technology transfer of ACTRIS projects, as well as participate in other cross functional project initiatives. Complete other relevant work arranged by Head, Laboratory and Production. What we are looking for Bachelors or Masters in Life Science / Biomedical Sciences / Chemical Engineering / Bioengineering / Bio-processing and other relevant scientific or engineering disciplines. Preferably 5 to 7 years of relevant experience in cell and gene therapy or related field such as biologics or biopharmaceutical processing. Prior technical knowledge in clinical or commercial manufacturing of specific cell types will be an advantage. At least 2 years of mid-management leadership experience, with track record of building and leading exceptional teams. Attributes Extensive experience in GMP cleanroom operations and aseptic processing. Strong knowledge and experience in cell therapy manufacturing (or upstream cell culture processes) and cryopreservation. Strong working knowledge of GMP guidelines and relevant regulatory knowledge (HSA, FDA, EMA, PICS). Highly skilled in applying Root Cause Analysis tools and in designing meaningful CAPAs. Technical writing skills for the authorship of internal/external documents and approve technical documents. Highly proficient with Microsoft Office Suite and able to efficiently utilize MS Excel, MS Word or MS Power Point for presentation and management reporting. A team player with good time management, interpersonal and communication skills. Highly motivated and self-driven with proven track record of delivering complex projects and working with multi-disciplinary teams. Able to work rotating shifts, as required. Excellent organizational, interpersonal, verbal and written communication skills. What you need to know Successful candidate will be offered a 3-year renewable contract. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below: CRIS – SCRI – NHIC – ACTRIS – PRECISE – STCC – CADENCE – #J-18808-Ljbffr

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