UNIVERSITY OF COLORADO DENVER | ANSCHUTZ MEDICAL CAMPUS
Allergy & Clinical Immunology
Position Number: 00783096
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.Nature of WorkThis full-time, faculty position will work at ClinImmune Labs which is within the Division of Allergy and Clinical Immunology. ClinImmune Labs provides stem cell banking, stem cell processing, clinical HLA testing for human stem cell and organ transplants, plays a key role in clinical trials conducted at UCH and has two FDA licensed hematopoietic stem cell products used for treating >100 patients per year. It also holds an FDA IND for use of umbilical cord mesenchymal stem cells in the treat of diabetic foot ulcers, and a patent for HLA gene editing for the treatment of rheumatoid arthritis. This position is responsible for providing research and clinical support to the ClinImmune Labs faculty, staff and rotating fellows in the areas of training, mentoring, assay development, procedure development, design of validation studies, quality improvement/control, and regulatory compliance.Professional FieldQuality Assurance/Immunology/Cell Therapy Examples of Work PerformedThe duties and responsibilities of the position include, but are not limited to:University of Colorado Cord Blood Bank/St. Louis Cord Blood Bank and Stem Cell Processing Laboratory- 60%
- Provide regulatory oversight of two FDA licensed hematopoietic stem cell products that are used to treat >100 patients per year.Organize and review quality systems including document control, internal and external inspections, validations and verifications, institutional review board (IRB) applications, amendments, and continuing review, corrective action and preventative action (CAPA) documentation and resolution proficiency testing, and quality improvement.Review clean rooms and processing for compliance with standard operating procedures (SOP) and regulations. Track and trend results of environmental monitoring including temperature, humidity, pressure graphs, and growth of viable particles. Maintain document control system, including “Master” and “Archived” files. Ensure documents are consistent, technically sound, and meet applicable regulations. Ensure all appropriate staff has trained on SOPs before implementation as a “Master” file.Prepare FDA IND (Investigational New Drug) and BLA (Biologic License Application) (specific focus on the technical aspects of manufacturing and quality testing) and FDA annual reports (e.g. safety reports, BLA annual report, Lot distribution reports and 483 inspections response).Perform Quality Assessment and review of occurrences (CAPA). Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution. Provide any necessary follow-up and/or documentation for process change requests and resolution.Review master batch records including donor eligibility infectious disease results, sterility results, hemoglobinopathy results, HLA results, and total nucleated cell (TNC) counts. Coordinate medical director review of product files, and independently approve products for release.Attend monthly meetings with University of Colorado Hospital Stem Cell Transplant staff to review quality improvement of the Stem Cell and Bone Marrow Transplant program.
- Provide regulatory oversight of research being conducted on ClinImmune’s patented HLA Gen Editing for the treatment of rheumatoid arthritis.Organize and review quality systems including corrective action and preventative action (CAPA) documentation and resolution, proficiency testing and quality improvement.
- Review initial training, annual continuing education competency, and SOP review.Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), AABB, College of American Pathologists (CAP), Foundation for the Accreditation of Cellular Therapy (FACT) and American Society for Histocompatibility and Immunogenetics (ASHI). Approve and submit annual documentation of facility accreditation. Must maintain knowledge of current standards and work with quality specialist to educate and train staff on compliance with all standards.Prepare for external inspections by accreditation agencies. Assist inspectors during on-site inspections.
- Provide regulatory oversight of 15+ clinical trials that are being run through ClinImmune.Organize and review institutional review board (IRB) applications amendments, and continuing review.Oversee inspection (audit) process for both internal and external entities including the design and performance of internal audits scheduling and coordinating audits and providing resolution for deficiencies. Summarize and present audit results at quality review meetings.Design work flow and validations/verifications plan for aseptic cell culture and testing in process development.Review and approve validation and verifications associated with process development and GMP activities.Planning and managing progress of process development to GMP activities.Audit inventory and clean rooms during process development and GMP activities.Development of SOPs for process development activities to meet GMP regulations.Initiate and monitor training and competency of staff performing process development activities to meet GMP regulations.Apply research laboratory experience such as aseptic cell culture, molecular and cell biology assays and flow cytometry in the development of processes, procedures and documentation to take Umbilical Cord tissue Mesenchymal Stem cel research through IND phase I.
- Provide training/mentoring to incoming technicians, researchers, quality unit staff, and rotating fellows.
- Education: Ph.D or its equivalent experience.Experience: Two (2) or more years of experience in laboratory medicine or regulatory affairs.
- Ph.D. in biological sciences, clinical laboratory sciences, or a related field.
- Experience with assay development and performance of molecular biology assaysExperience with administering training and mentoring
Job Category: Faculty
Primary Location: Aurora
Posting Date: Apr 29, 2021
Unposting Date: Ongoing