Apply for Job Job ID361973 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code9354S1 Employee ClassAcad Prof and Admin Add to Favorite Jobs Email this Job About the Job The Division of Gastroenterology, Hepatology, & Nutrition is recruiting a Research Support Manager 1 to oversee the clinical and manufacturing arms of the Microbiota Therapeutic Program (www.microbiota-therapeutics.umn.edu/), which develops live biotherapeutic products that target the gut microbiome. The Program serves as a central hub for multiple collaborations within and outside the University of Minnesota performing clinical trials. Some of the therapeutic targets include inflammatory bowel diseases, optimization of cancer immunotherapy, complications of advanced liver disease, antibiotic resistance, C. difficile infections, and autism. Our portfolio of products includes several formulations of healthy donor microbiota, some of which are rationally selected in microbial composition for specific disease indications. All formulations are being developed with an eye for potential wide applicability through commercial licensure. The individual well suited for this position will have a solid understanding of Good Manufacturing Practices and will need to become intimately familiar with our protocols and standard operating procedures. Since we ultimately want to see FDA approval for our products, prior industry experience will be especially preferred. The following will be some of the immediate challenges that will need to be tackled by this individual: 1. Lead the development of the Drug Master File that describes the manufacturing of all our products. Currently, the manufacturing is described in our multiple Investigational New Drug Applications. However, a single Drug Master File is now being requested by the FDA. 2. The individual must become intimately familiar with our SOPs in GMP manufacturing, which means he or she will need to do hand-on work in production in the Molecular and Cellular Therapeutics (MCT) facility (the GMP facility of the University). The individual will also participate in the development of new SOPs. The mastery of the processes must reach the level of our current MCT Production Manager to enable supervisory responsibilities at the production site when needed. 3. Learn to function as a clinical trials monitor (if needed, training will be provided). This function will become increasingly necessary for the conduct of multi-center trials and design of clinical trials that have the potential to lead to FDA licensure. Effort in the first year will be approximately distributed in the following way: 40% Working directly in the manufacturing suite alongside laboratory technicians and the MCT Production manager to enable mastery of the SOPs. 40% Development and submission of the Drug Master File. 20% Develop familiarity with the ongoing clinical trials and prepare to function as a clinical trial monitor. The precise functions may change after the first year as the needs of the program are rapidly evolving. Qualifications The responsibilities will require the following required qualifications: 1. BA/BS with at least 6 years of experience or advanced degree with 4 years of experience. 2. Ability to solve complex problems with few or no existing practices already in place. Must be able to adapt to evolving policies and regulations, requiring ingenuity with regards to resolving issues. 3. Ability to work independently and able to make decisions with minimal guidance from the PI. 4. Ability to supervise and work productively with multiple research staff members. 5. Experience with budget management to optimize resource utilization and maintain cost-effectiveness. 6. Experience with drafting and managing SOPs and maintaining document control. 7. Hands-on laboratory experience in medical biosciences. Preferred qualifications include: 1. History of creation and management of new research programs in a ademia and/or industry. 2. A strong understanding and experience with regulatory policies, such as FDA, NIH, and IRB. Must be able to interpret how regulations impact various research projects apply this to the development of study protocols. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer contribution Public Service Loan Forgiveness (PSLF) opportunity Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Employee Transit Pass with free or reduced rates in the Twin Cities metro area Please visit the Office of Human Resources website for more information regarding benefits. How To Apply Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647. Diversity Employment Requirements Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment. About the U of M The University of Minnesota, Twin Cities (UMTC) The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019,... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.