Manager, laboratory and production, actris

2 weeks ago

Singapore Outdoor Venture Pte Ltd Full time

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) National Health Innovation Centre (NHIC) Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) Precision Health Research, Singapore (PRECISE) Singapore Translational Cancer Consortium (STCC) 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 Oversee production of cell-based therapy products in ACTRIS GMP facility including cell processing, product storage, shipments etc. Manage all aspects of laboratory operations, which include planning production schedules, resolve operational issues and efficient allocation of manpower and resources. Develop and implement production-related workflows and processes appropriate for clinical stage and commercial manufacturing. Ensure compliance to Good Manufacturing Practice (GMP) guidelines and relevant safety requirements. Oversee qualification and maintenance of equipment and clean rooms within the facility. Collaborate with other functions to facilitate new product introduction and technology transfer of ACTRIS projects, as well as participate in other cross functional project initiatives. Participate in the development of new manufacturing processes, process improvement and risk assessment activities. Support manufacturing-related change controls; as well as deviation investigations and follow up with appropriate corrective or preventive actions. Ensure GMP inspection readiness of the team. Lead and/or support internal audits and external inspections. Support Head of Department to manage projects, budget, and resources to achieve departmental and organization goals. Manage training of staff according to training plans, provide guidance and performance feedback to develop staff and team competencies. Drive safety and quality culture within the team. What we are looking for EDUCATION, TRAINING : Bachelors or Masters in Life Science / Biomedical Sciences / Chemical Engineering / Bioengineering / Bio-processing and other relevant scientific or engineering disciplines. EXPERIENCE : 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 will be an advantage. At least 2 years of people management experience. ATTRIBUTES : Familiar with GMP cleanroom operations and aseptic processing. Experience with cell culture processes and/or cell therapy manufacturing. Knowledge of c GMP and relevant regulatory requirements related to cell therapy manufacturing. Adaptable to change and able to navigate through ambiguity, especially in start-up environment. Ability to be agile and collaborate effectively with different stakeholders. Proficient in standard Microsoft Office applications e.g. MS Word, Excel and Power Point. Fluent in written and verbal English. What you need to know Successful candidate will be offered a 3-year renewable contract. Only applications via this link will be reviewed. 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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