The University of Minnesota Molecular and Cellular Therapeutics (MCT) is a GMP manufacturing facility within the University division of Office of Academic Clinical Affairs. The manufacture of Cellular Translational Somatic Cell, and Standard of Care Cellular comprises about 90% of the clinical products manufacturing activity within the facility. Additional activity includes, but may not be limited to clinical related production of pancreatic islets, fecal microbiota and active pharmaceutical and drug products.
The Director of Quality Assurance/Regulatory Affairs is responsible for the oversight of the quality aspects and assurance that the clinical productions meet the Food and Drug Administration (FDA) and University of Minnesota regulatory requirements. The oversight includes FDA Phase I and II INDs (Investigational New Drug Application) and Public Health Service Standard of Care biological and drug products manufactured within the facility.
The Director works closely with and collaborates with the facility Medical Director, Scientific Director, Facility Director, clinical study investigators and sponsors in addition to the University programs utilizing the facility for manufacture of their clinical products.
This position is located on the University of Minnesota St. Paul campus and requires in office/facility work. The position is eligible for University of Minnesota Professional and Administrative (P&A) health benefits and vacation/sick time per University policies. Primary Duties
50 % - Ensure the MCT Quality System Management is effective, efficient and results in facility compliance with US Food and Drug Administration (FDA) regulations applicable to: Investigational New Drug Applications (INDs), Public Health Service 351/361 regulations, Good Manufacturing Requirements (GMPs) and Good Clinical Practice (GCP) requirements. Evaluate and resolve quality and regulatory compliance discrepancies.
10 % - Management of IND product release for distribution to ensure quality and regulatory requirements are met; production discrepancies are documented, evaluated and resolved. Additionally, participate in IND CMC input and review.
10 % - Collaboration with study sponsors, principal investigators MCT facility medical and facility directors in addition to University of Minnesota staff external to the MCT.
10 % - Management of the facility clean room environmental monitoring program to proactively prevent facility and product microbial contamination.
10 % - Development of study sponsor Quality Agreements, review of internal quality indices, quality/compliance internal and external audits and the development of internal quality related reports.
10 % - Staff supervision and other miscellaneous duties. Required Education and Experience Bachelor degree of Science with a least 10 years of combined education and the following work experience: Working within a FDA regulated Cell/Tissue or Blood quality/compliance setting. Working with Phase I/II INDs. Collaboration with study investigators and study sponsor. Hosting federal/local, sponsor, accreditation and internal inspections and audits. Management/oversight of quality systems associated with biologics and drug manufacture. Development and review standard operating procedures and product standards. Staff supervision. Or advanced degree with 8 years of experience.
Preferred Education and Experience Master degree in Quality Assurance or FDA Biologics/Drug Regulatory Compliance. Educational curriculum and/or experience that includes cell processing, microbiology, active pharmaceutical, laboratory science and review boards. About University of Minnesota Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.
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