GMP MANUFACTURING TECHNICIAN - Marcus Center for Cellular Cures
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
DukeUniversity’s Marcus Center for Cellular Cures (MC3) has an immediate openingfor a Manufacturing Technician in our GMP Manufacturing Laboratory.
Our Vision: To live in a world where every person has access to high quality and effect ivecell based therapies
Our Mission:Together we desig n, develop and deliver the highest quality cellular therapiesto improve health
Moreinformation is av ailable at the following link: https://marcusc enter.duke.edu/
The incumbentin this position is responsib le for highly complex and specializedmanufacturing of cellular products for clinical trials and commercialoperations. In addition, this individu al will be responsible for supporting thedaily operation of the GMP faci lity to ensure it is in control and incompliance with applicable regulat ions. The individual filling this positionwill be an integral member of a team working together to produce the highestquality clinical material for novel cellular therapies.
Perform dutiesas dictated by standard operating procedures (SOPs) for cellular productmanufacturing and under G’X’P (GLP , GTP, GMP, GDP) guidelines as directed.Perform duties in a clean room environmentwhile fully gowned (hood, mask, coverall, boots , gloves, etc.) following GMPguidelines and using aseptic technique. Per form cell culture of a variety ofcell and tissue types using various ves sels and media formulations tospecifications outlined in batch records. Operate instrumentation needed forcell manufacturing including but not l imited to cell separators, cell counters,centrifuges, incubators, pipett es,and Biological Safety Cabinets. Accuratelycomplete batch record docu mentation, all appropriate equipment log entries, andGMP documentation. Maintain responsibilityand confidentiality for patientidentification, s pecimen labeling and specimen verification.
Work with LabManager, other GMP Manufactu ring Technicians, and Quality Assurance to ensurethe facility is in comp liance for governing regulations. Maintain orderly labspaces. Participat e inlab inspections and work with inspectors as needed.R ecord and inform of any insufficientinventory of supplies and reagents; clean and maintain laboratory equipment ingood working order< p>
Prepare andqualify reagents, stains, so lutions, chemicals, and culture media asappropriate. Use knowledge of la boratory safety and infection controlprocedures and practices to safely perform required work including universalprecautions and hazardous chemi cal handling.
Assist intech nology transfer of manufacturing processes from pre-clinical into GMPenv ironment.
Use dexterity,know ledge, and ability to complete assigned laboratory tasks and skills, wit hattention to detail and compliance with all appropriate laboratory regu latoryand safety requirements.
Ability to workand maintain strong relationships with the department manager, members of theGMP team and other departmental staff.Ability to read and understand StandardOperating Procedures.