The University of Maryland NCI-designated Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking qualified applicants for the newly established Hamish and Christine Osborne Director of Cellular Therapeutics. The Director will provide expert technical and managerial leadership as the Laboratory Director of Cellular Therapeutics. Cellular Therapeutics Laboratories include the UMGCCC clinical laboratory, a FACT-accredited blood and marrow stem cell processing laboratory, and the new cGMP cell processing facility at our academic research institution.
Responsibilities will include:
- Managerial and technical oversight of the UMGCCC Cell Therapy Laboratory, a well-established and FACT-accredited blood and marrow stem cell processing laboratory currently staffed with 4 technical specialists; the lab supports the UMGCC Blood and Marrow Transplant ProgramÂ¿s 150-200 transplants per year.Â
- Support for the construction, commissioning and validation of the clean room facility in compliance with FDA guidelines for cGMP operations as they apply to processing of cellular products.
- In concert with the UMGCCC physician leaders, the position will provide senior leadership for the facility to include (1) hiring, supervising, mentoring and career development of manufacturing staff; (2) developing facility policies and Standard Operating Procedures; (3) interacting with academic and clinical regulatory groups such as Quality Assurance Unit, IRB, FDA, FACT, etc.
- Identifying, educating and recruiting potential stakeholders in cGMP cell therapeutics.
- Collaborating with clinical investigators by providing (1) process development and validation for the manufacture of new cell therapies; (2) authorship, review and approval of the CMC documentation for regulatory filings; (3) cooperation and engagement with regulatory agencies as required by the project.
- Managing day-to-day operations of both facilities, operational budgets and service contracts.
- Devising strategic plans and participating in the UMGCCC NCI-funded P30 center grant application; developing and expanding the cGMP lab for consideration as a UMGCCC Shared Service, defining long-term strategic goals, identifying future directions, and enhancing the scope of the service by identifying and capturing grant funding such as NIH shared instrumentation grants.
While the UMGCCC Stem Cell Processing Laboratory is well established, the cGMP Facility is currently under construction. It will provide investigational cell processing services to UMGCCC investigators, other UMB investigators and to other clients based partly on the directorÂ¿s marketing activities.Â Funding for this position will be partially endowed by a major philanthropic gift; the holder will be the Â¿Hamish and Christine Osborne Director of Cellular TherapeuticsÂ¿.Â Â