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Quality Systems Manager

Position Summary: The Quality Systems Manager will be responsible for ensuring compliance with all Federal and State regulations governing the manufacturing of cell therapy products. The QS Manager will oversee the production, distribution and review of documentation related to manufacturing and release testing of products; will ensure facilities and manufacturing operations are conducted according to cGMP. The QS Manager provides training and certification of manufacturing and QC staff, controls distribution, tracking and archiving of clinical materials and provides validation support for all equipment, processes, and approves all outcomes, which are essential to the production of biotechnical products. The QS Manager will act as a liaison and interact with clinical and research investigators, regulatory affair staff and vendors.

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Cellular Therapy Technologist, Manufacturing

Position Summary:  This Cellular Therapy Technologist will provide technical support to programs within Ossium Health’s Manufacturing group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical manufacturing.  This work will involve executing and documenting methods for the manufacture of bone marrow-derived products.  It will also involve the implementation of new methods as designed by senior staff.

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Senior Cellular Therapy Technologist, Manufacturing

Position Summary:  This Senior Cellular Therapy Technologist will provide technical support to programs within Ossium Health’s Manufacturing group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use.  This work will involve executing and documenting the established methods as well as methods in development.  It will also involve the implementation of new methods and comprehensive technical oversight of manufacturing facilities.

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