The Academic Health Center (AHC) of the University of Minnesota is seeking to fill the position of Biotherapeutics Manager for its Molecular and Cellular Therapeutics Facility.
The Manager will be responsible for: 1) oversight of the production and quality assurance of all clinical trial materials produced in a 33,409 sq ft production facility; 2) monitoring performance of all internal and external contracts for the production of biologicals under FDA cGMP regulations; and 3) supervision of facility personnel and program budget. In addition, the Manager will work closely with AHC faculty in the development of documentation and appropriate release testing for a variety of biological products to include gene therapy vectors, cancer immunotherapy, xenotransplantation, and islet transplantation.
Candidates must have a Bachelor’s degree (Masters or Doctorate preferred) in the biological sciences, chemistry, or biomedical engineering or related field, and optimally at least 5 years experience in the field of biotechnology with a broad perspective on all aspects of clinical production to include an understanding of the issues of process development, Quality Control, and Quality Assurance as they relate to biological materials intended for use in clinical trials. Experience working with the FDA on the CMC sections of IND applications and with FDA audits will be important considerations.
Applicants should send a letter of application and resume/curriculum vita by February 1, 2003 to:
The University of Minnesota is an Equal Opportunity Educator and Employer.
University of Minnesota, Academic Health Center
John E. Wagner, M.D., Chair, Search Committee
Scientific Dir., Molec. & Cellular Therapeutics
MMC 366, 420 Delaware St. SE
Minneapolis, MN 55455
University of Minnesota, Academic Health Center is an Equal Opportunity Employer