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 and complete one year of training in the Vector Production Facility or have three years of lab 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 Good Manufacturing Process (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.
Master's degree in basic science field. Experience in a Good Manufacturing Process (GMP) environment. Working knowledge of GMP and FDA biologics regulations.
Working Conditions / Demands
Willing to have flexible work hours with occasional weekend work and on call time. Able to lift up to 50 pounds at a time, lift or carry objects weighing up to 25 pounds frequently. Spend long periods of time in a cleanroom laboratory environment. Light work (lifting, bending, crouching/squatting, carrying). Standing for moderate amounts of time. Have the degree of sight that enables review of data/documents and observation of laboratory.
Salary Plan: TE
Salary Grade: SR1
Job Function: Health Services
This posting is scheduled to close at 12:01am EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but it 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.
Equal Employment Opportunity
Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information .
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at email@example.com or by visiting IUPD.
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.