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 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 Standard Operating Procedures and collaborate with investigators in translation of bench-scale techniques to large-scale production. Person will work closely with team members to assure compliance with regulatory requirements.
Education and Experience:
Bachelor’s degree in a discipline related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Knowledge and experience in aseptic technique and manual mammalian cell culture. Willing to work in cleanroom environment with potentially infectious materials. Demonstrated and extensive skills in the operation and troubleshooting of complex laboratory machines (e.g. automated immunomagnetic separation devices). Proficiency with MS Office.
Minimum of Bachelor's Degree in biological or chemical science (or equivalent) and two years of experience in cellular therapy production highly desired. Prior experience working with transducing retrovirus for manufacturing of human cellular therapy products in a Good Manufacturing Practice (GMP) environment is highly desired.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.