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GMP Operations Senior Manager

Position Summary: Responsible for managing all activities and daily operations in the cell production and manufacturing facilities. Knowledge of hematopoietic stem cell (HSC) processing, mesenchymal stem cell (MSC) processing/manufacture, cellular analysis, aseptic operations, and support systems are essential. Demonstrated managerial skills and a strong working knowledge of regulatory compliance requirements for the production of biologics used in clinical studies are essential. Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical processing/manufacturing requirements and develops/modifies production methods to fully address such issues. Prepares validation protocols, SOPs, material specifications and develops new client master batch records. Manages cell manufacturing operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the U.S. FDA GMP regulations.

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Scientist – Stem Cell Biologist

Position Summary: The ideal candidate for this position will hold a PhD with 0-5 years of experience following completion of training. The overall Research focus of this position will be to develop methods for isolating and characterizing stem and progenitor cells from whole, deceased donor bone marrow. Of particular need is isolation of hematopoietic stem and progenitor cells; thus, previous experience with mononuclear cell enrichment and CD34+ selection is highly desired. Experience with isolating and/or propagating other stem, committed progenitor and mature cell types, such as mesenchymal stem/stromal cells, common lymphoid/myeloid progenitors and T cells, would also be of interest. This work will involve adapting established methods as well as developing and implementing novel methods and tools when required. This position will report directly to the Director of R&D.

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Laboratory Technologist-I, Production (Weekends)

Position Summary: Laboratory Technologist will perform tissue processing to recover stem cells from human tissue and assist with testing of cells as needed. Responsible for weekend coverage (day shift) and 3 weekdays (Wednesday-Sunday or Saturday-Wednesday).

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Document Control Manager

Position Summary: The document control manager is an integral part of the Ossium Health Quality Management System (QMS). This position is responsible for control, security, accessibility, and timeliness of organizational documents such as policies, procedures, guidelines, forms, templates, and training materials.

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