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.

Molecular and Cellular Therapeutics

Bringing together regulatory, quality, product development, manufacturing and facilities engineering expertise to the translation of novel, experimental research into medicine for use in human clinical trials.

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
• 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)
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

Please visit the for more information regarding benefits.

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-UOHR (8647).

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:

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.

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, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).