Summary of Position: Our research program is focused on development of novel therapeutics composed of intestinal microbes. Specifically, microbes separated from healthy human stool are formulated as freeze-dried, encapsulated or frozen/liquid formulations. The entire process is done using current Good Manufacturing Practices (cGMP) in the Molecular and Cellular Therapeutics Facility at the St. Paul campus. The microbiota preparations are used to treat patients suffering with Clostridiodes difficile infections or used in a number of early phase clinical trials, including ulcerative colitis, autism, advanced liver disease, as adjuncts to cancer therapies, and other emerging indications. The individual will be part of an established team and assist in all aspects of the manufacturing process.
Essential and Other Functions: 75 % Production Process • Participates in all aspects of the production process in accordance with current Good Manufacturing Practice (cGMP) requirements using Good Documentation Practices (GDP). • Follows safety requirements, maintains good housekeeping of lab areas and performance of the program. Provides feedback on recommendations for procedural and process improvements.
20 % Lab Maintenance • Performs routine preparation of equipment and materials for daily production operations. • Assists with site equipment installation, operation and performance qualifications as required.
5 % Collaboration with Lab Members • Utilizes process knowledge to collaborate with co-workers during the review and revision of Standard Operating Procedures (SOPs) and other process documentation. • Informs co-workers of all relevant events impacting the operations and performance of the program. Provides feedback on recommendations for procedural and process improvements.
Essential Qualifications B.S. in Biological Sciences with a major in Microbiology, Biochemistry, Molecular Biology, Biology, Genetics, or related discipline. Minimum of 1 year of professional laboratory experience or a combination of education and work experience to equal five years.
Preferred Qualifications: Working knowledge of GMPs and GDPs. Laboratory experience with microscopy. Familiarity with executing SOPs in a laboratory or manufacturing environment, preferably in the pharmaceutical industry. Understanding of the importance of documentation and data traceability.
Internal Number: 338561
About University of Minnesota, Twin Cities
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