Develop processes for purification, genetic modification, and expansion of various primary cell types for clinical trials. Creates new procedures to support PI-initiated clinical protocols and scale-up of products for manufacturing. Manufacture gene modified cellular products for clinical trials. Ensure processes meet the requirements for cellular therapeutics as mandated by the Food and Drug Administration and other regulatory agencies. Schedule and coordinate assignments of process development and manufacturing personnel and coordinates with other cGMP facility departments, clinical team, human application lab, and vector lab to achieve manufacturing goals. Ensure that all manufacturing personnel receive appropriate training.
Bachelor's Degree in Biological Sciences or related field. MS or PhD preferred
With a bachelor's degree, 12 years of related experience required. With a Masters, 8 years of related experience required. With a PhD., 4 years of related experience required. Experience in process development in a cGMP environment is preferred. Experience in culturing and transducing immune cells and hematopoietic cells preferred. Proficiency in flow cytometry preferred.
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.