GMP Research Associate
GMP Research Associate
The person in this position will be responsible for the production of human cellular therapy products intended for administration to patients enrolled in clinical trials following all regulatory requirements to ensure compliance with federal and state statutes. Cell products may be from patients with infectious diseases including HIV. Production will be guided by specific procedures and accurately documented in completely filled out manufacturing records. Sampling and analysis for quality control purposes, product and sample inventory storage, transportation (position requires that the employee use their personal vehicle to transport samples from facility on Hwy 54 to UNC campus) and shipping of product/samples, materials tracking and management, and data collection/reporting are additional functions in this position. Person will take lead in developing SOPs and collaborate with investigators in translation of bench-scale techniques to large-scale production. Person will work with team members to assure compliance with regulatory requirements. The position requires experience related to technology, public health research, oversight of large-scale data collection efforts, IRB applications, and project management. The Project Director will have regular contact with the research partners, policy makers, government agencies, and will supervise two full time research assistants, one full time study coordinator, and various undergrad/graduate student data collectors. The Project Director will serve a critical role in the communication and coordination among internal and external study partners, dissemination of research findings, as well as assuring the timely implementation of research and practice projects related to tobacco and alcohol use prevention and control.
Knowledge and experience in aseptic technique and manual mammalian cell culture. Willing to work in clean room environment with potentially infectious materials. Demonstrated and extensive skills in the operation and troubleshooting of complex laboratory machines (e.g. automated immunomagnetic separation devices). Experience in cellular therapy production. Proficiency with MS Office. Valid NC driver's license.Post-Bachelor's degree in biological or chemical science (or equivalent) or a Bachelor's and three years of relevant experience.
American Recovery & Reinvestment Act Funded:
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