The Vector Production Specialist is charged with manufacturing lentiviral and retroviral vectors 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 viral vectors following GMP requirements 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 and have the ability to assist in decisions making that can impact product safety. Vector Production 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) 3 practices as defined by the Centers for Disease Control. The Vector Production Specialist must follow current Standard Operating Procedures (SOPs) and is involved in the writing and revision of SOPs. All processes performed in vector production are documented per SOP specifications.
Bachelor's degree in science or a health-related field and one year of laboratory experience.
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. Able to organize, prioritize, and complete multiple assignments independently. Knowledge of laboratory safety practices.
Master's degree. GMP experience. Knowledge of GMP and FDA biologics regulations.
Working Conditions / Demands
Ability to occasionally move objects weighing up to 50 pounds and move objects weighing up to 25 pounds frequently. Ability to spend long periods of time in a cleanroom laboratory environment. Light work (lifting, bending, carrying, etc.). Ability to review data/documents and observe the laboratory. Willingness to have flexible work hours with occasional weekend work and on call time.
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.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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About Indiana University Purdue University Indianpolis - IUPUI
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.