The University of Maryland NCI-designated Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking qualified applicants for a faculty level Operations Director for the our newly established 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:
- Daily technical & operational 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 Program's 150-200 transplants per year.
- 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 day-to-day 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.
- Assist in identifying, educating and recruiting potential stakeholders in cGMP cell therapeutics.
- Supporting collaboration 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 in concert with UMGCCC administration.
- 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 director's marketing activities.
Required: Doctoral degree (PhD or MD or VMD) in biomedical sciences with at least 2 years postdoctoral training in biomedical research, ideally in a field related to cancer research or immunology. A minimum of 5 years' hands-on experience in a cGMP or GCP cell processing facility is required, including 3 years' managerial and/or quality management experience strongly preferred. Strong laboratory skills in cell processing, immunology and tumor immunology are essential. Demonstrated comprehension and compliance with various regulatory, accreditation and licensure requirements (FDA GxP, FACT, etc.). Salary will be commensurate with qualifications and experience.
Desired: Managerial experience with running a laboratory or shared service/core facility in a biomedical research environment. Training and/or teaching experience with students, fellows, technicians.
Please apply directly and forward CV and names of four references to Ms. Athena Baxivanos at email@example.com.
Expected faculty rank is Assistant Professor or higher, however, rank, tenure status and salary will be dependent upon selected candidate's qualifications and experience
Organization: SOM Centers/Programs/ORCs
Job Posting: Oct 18, 2017
Internal Number: 73281
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.