The Cell Immunotherapy and Transduction Specialist is charged with manufacturing cell immunotherapy product for use in FDA-regulated Phase I/II clinical trials. Manufacturing must be according to Good Manufacturing Practice (GMP)-compliant processes, as defined in Chapter 21 of the Code of Federal Regulations (CFR), for use in human clinical trials. It is critical that this position manufacture cell products following GMP requirements, Foundation for the Accreditation of Cellular Therapy (FACT) Standards and FDA and State regulations, including the production of sterile drug products, to ensure the safety of patients receiving these products. Thus, the employee must develop an understanding of FDA and state regulations, including aseptic processing of products. The employee must become fully aware of the critical work environment and understand required ranges for the cleanroom environment and equipment. The employee must develop and maintain competency to assist in decision making that can impact product safety. Cell manufacturing requires the use of ISO 7 and ISO 8 certified cleanroom facilities and ISO 5 certified biological safety cabinets, specialized gowning and personal protective equipment, and aseptic technique. Staff must follow Biosafety Level (BSL) 2 practices as defined by the Centers for Disease Control. The Cell Immunotherapy and Transduction Specialist must follow current Standard Operating Procedures (SOPs) and is involved in the writing and revision of SOPs. All processes performed in cell manufacturing are documented per SOP specifications.
Bachelor's degree in a basic science field and one year of experience in a GMP environment.
Experience in cell culture using aseptic technique. Ability to work in a cleanroom using BSL3 practices. Strong technical and communication skills. Ability to make decisions based on standard operating procedures, laboratory practices, and GMP. Knowledge and ability to follow sterile technique in laboratory assays. Ability to organize, prioritize, and complete multiple assignments independently. Knowledge of laboratory safety practices. Willingness to have flexible work hours with occasional weekend work and on-call time.
Bachelor's degree in Medical Technology. Working knowledge of GMP and FDA biologics regulations.
Working Conditions / Demands
Tasks related to the position:
Move objects weighing up to 50 pounds, move objects weighing up to 25 pounds frequently.
Spend long periods of time in a cleanroom laboratory environment.
Review data/documents and observe laboratory.
Salary Plan: TE
Salary Grade: SR1
Job Function: Health Services
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.