The Indiana University Gene Therapy Testing laboratory (GTTL) analyzes samples from products manufactured as Indiana University as well as products and clinical trial participant specimens from multiple other academic and biotech companies. The data from this laboratory is used to (1) provide evidence to the FDA that a product is safe for use in humans in early phase trials, (2) Provide evidence to clinical investigators and the FDA that there is no indication of adverse events related to the molecular therapy and (3) move its testing services beyond Phase I/II to handle Phase II, III and even licensed product testing due to the changes in the national gene therapy landscape. This requires a much higher level of compliance, qualification and oversight. The contribution of the GTTL has also resulted in a government contract from the NIH. This position will be required to perform a series of assays to meet the requirements above. The assays must be performed in compliance with Standard Operating Procedures (SOPs) and governmental regulations. The role is responsible for completing all paperwork as described in SOPs and any non-conforming results require the technician to participate in a Root Cause Analysis and completion of Deviation Reports and Out-of-Specification reports. The individual is responsible for working with the Manger, Director and the GTTL Quality Assurance Specialist in training of assigned assays (as described in SOPs). As needed, the technician will participate in all audits by governmental agencies and clients. The NIH contract and other grans will require the IU GTTL to develop novel GMP testing for emerging technology. The individual should be prepared to undergo training in and participate in novel biologic and molecular assays as the field of gene therapy is rapidly evolving and new techniques and tests are required to assist gene therapy investigators in meeting FDA testing requirements (at times the IU GTTL will work with the FDA in developing the assays that will define the FDA testing requirement). Work must be performed with detailed attention to confidentiality, both for samples related to patient testing and for commercial vector testing to protect the intellectual property rights and trade secrets of the client. Some assays performed will require positive control viruses including but not limited to: attenuated HIV-1, murine gamma retroviruses, measles virus, vaccinia virus, and Sendai virus. Human and animal cells and cell lines will be used in the assays. Employee must maintain up to date training on assay proficiency and GMP training as prescribed in IU GTTL SOPs.
Medical Technologist or bachelor's degree in a basic science area and five years of GxP (GMP, GLP, GTP, CAP or CLIA) laboratory experience.
Experience with cellular and/or molecular testing. Familiarity with standard office and client specialized software programs. Ability to effectively communicate and exchange information.
Working Conditions / Demands
Extensive sitting, standing, and moderate lifting. Fine motor skills and periodic extended work days.
Salary Plan: TE
Salary Grade: 09
Job Function: Research
This posting is scheduled to close at 11:59pm 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.
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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.