drjobs Director of Cell Therapy and Regenerative Medicine CTRM

Director of Cell Therapy and Regenerative Medicine CTRM

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Job Location drjobs

Salt Lake, UT - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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We are expanding our Cell Therapy and Regenerative Medicine CTRM Program and are seeking an MD/DO or PhD with expertise in cellular therapy (CT) and/or regenerative medicine (RM) to oversee all aspects of the CTRM program. The CTRM is jointly administered by the Division of Hematology and Hematologic Malignancies and the Department of Internal Medicine. The successful candidate will be provided with a faculty appointment in the Division/Department and become an investigator in the Huntsman Cancer Institute. The responsibilities of this position include: Oversight of preparation and analysis of all blood and marrow transplant products and all experimental cellular therapy products in close collaboration with the Clinical Director the Cellular processing Director of CTRM and the Director of the Blood and Marrow Transplant and CT Program to ensure optimal BMT patient care. Continual monitoring of production methods in current use and their updating consistent with current best practices as reported in the relevant scientific literature. Development of clinicalgrade cellular therapy products as required for stateoftheart clinical trials. Working collaboratively with the Quality Assurance team for CT and the performance improvement process to identify and correct potential risks to product quality or safety. Design and implement SOPs for all processes related to cellular collections. Working collaboratively with the Institutional Office of Regulatory Affairs to produce IND submissions and other FDA filings that may be required for cellular therapy products manufactured in the CTRM facility. Overseeing research operations for CTRM including developing a research strategy facilitating implementation administering research funds and working collaboratively with investigators using CT products in their clinical trials at all stages of trial conduct including design grant preparation event tracking and preparation of resultant manuscripts. Identification and pursuit of extramural funding opportunities and submission of grant applications. Recruit and work collaboratively with the Associate Director of RM to synergistically process and prepare products for experimental and clinically relevant materials including assisting in regulatory and process development. Overseeing all aspects of the CT fellowship in conjunction with the CT fellowship director. Applicant Minimum Requirements: MD/DO or PhD degree in biochemistry biology or a related field. Preferences: Experience in the following areas: Hematopoietic progenitor cell transplantation principles and practices Regulation and accreditation requirements for cell processing facilities in a particular foundation for accreditation of cellular therapy FACT GTP 21CFR1271 and GMP 21CFR211 21CFR610 Expertise in conducting CT research. Expertise in cell processing and cell cryopreservation methods Cell culture methods for the preparation of therapeutic cells Cell separation technology including CliniMacs immunomagnetic systems Master process record and batch process record development and maintenance including electronic recordkeeping system requirements. Interested candidates should submit a Curriculum Vitae with a letter of interest and letters of recommendation (multiple preferred) at the following link: Inquiries should be sent to: Dr. Ramiro Garzon at CTRM at the University of Utah provides safe highquality products for therapeutic use and research in support of The University of Utah Transplant and CT Program at Huntsman Cancer Institute and Primary Childrens Hospital. CTRM facilitates the availability of cellular and tissuebased therapies to patients by bridging efforts in basic research bioengineering and the medical sciences. CTRM has the expertise and infrastructure to address complex regulatory financial and manufacturing challenges associated with delivering cell and tissuebased products to patients. CTRM has a robust research and development program of cellular and acellular biological products for therapeutic and clinical applications. CTRM develops tests and manufactures its own inhouse products and therapeutics and has patents and intellectual property on its proprietary processes. CTRM collaborates with the University of Utah other University investigators and industry partners on novel products and therapies. The CTRM fellowship in Cellular Therapy includes all essential clinical operational technical regulatory and quality aspects of cellular therapy including elements of regenerative medicine. Throughout the year fellows will be expected to participate in clinical rotations and didactic activities to fulfill the educational objectives shown below. Additionally fellows are expected to design one clinical research project that might lead to an extension of the fellowship to an additional year as needed for its completion. The Division of Hematology and Hematologic Malignancies offers numerous opportunities for clinical translational and basic research with mentoring by internationally respected Hematologists and provides ongoing collaborative and infrastructure support for academic programs. Our vision is to establish an interdisciplinary stem cell and regenerative medicine program serving the Intermountain region of the US. Located in the foothills of the spectacular Wasatch Mountains the University of Utah is the States academic flagship institution. The Hematology Division is one of the oldest and most highly respected programs in the US. Salt Lake City has been recently voted one of the best places to live in the country and the city has been cited for cultural diversity convenient and affordable living an outstanding school system and unrivaled accessibility to outdoor activities. For more information on living in Utah please visit . The University of Utah Health (U of U Health) is a patient focused center distinguished by collaboration excellence leadership and respect. The U of U Health values candidates who are committed to fostering and furthering the culture of compassion collaboration innovation accountability diversity integrity quality and trust that is integral to our mission.


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