Analyzes samples from products manufactured at Indiana University as well as products and clinical trial participant specimens from multiple other academic and biotech companies. Uses data to provide evidence to the FDA that a product is safe for use in humans in early phase trials, to show that there is no indication of adverse events related to the molecular therapy, and to move testing services to the next phase.
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 provide evidence to the FDA that a product is safe for use in humans in early phase trials, provide evidence to clinical investigators and the FDA that there is no indication of adverse events related to the molecular therapy and 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 grants 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.
Duties in the original description are similar; however, the scope and level of governmental regulations has been drastically increased. Prior work was done as a member of the IU Vector Production Facility (IUVPF). The IUVPF has been dissolved and broken into separate organizations. Relevant to this employee, the Certification Laboratory within the IU VPF will now be a separate entity and has been renamed the IU Gene Therapy Testing Laboratory (GTTL). The IU VPF previously restricted work to research activities covered under Phase I/II FDA regulations. The international gene therapy landscape has broadened, and to remain competitive, IU Certification Laboratory needs to move its testing services beyond Phase I/II to handle Phase II, III and even licensed product testing. This requires an increased level of compliance, qualification and oversight. The contribution of the GTTL has also resulted in a government contract from the NIH.
Testing in the GTTL requires strict adherence to government regulations as defined in CFR 21 under Good Manufacturing Practice (GMP) regulations and guidelines. The employee must perform duties in compliance with Standard Operating Procedures and governmental regulations. They are responsible for review and assistance with Root Cause Analysis for all Deviations and Out-of-Specifications following IU GTTL SOPs. They are responsible for working with the GTTL Director, Manager, Supervisor, and Quality Assurance Specialist in review of all SOPs and in participation in all audits by governmental agencies and clients.
The new NIH contract also requires the IU GTTL to develop novel GMP testing for emerging technology, including insertion site analysis using high throughput gene sequencing to screen patients treated with gene therapy for cancer due to the gene therapy (vector insertion in or near oncogenes). The contract also requires development of testing for the emerging gene editing (CRISPR) technology. The employee will be required to participate in assay development that will eventually lead to FDA recognition as a suitable test for novel therapy that are still in the development stage.
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 and failure to perform adequately in this position can result in inaccurate testing results which could lead to:
1. Death of one or more research subjects treated with gene therapy products certified by the IU GTTL. 2. Serious illness of one or more research subjects treated with gene therapy products certified by the IU GTTL. 3. Lawsuits by commercial or academic clients to Indiana University due to harm to patients. 4. Lawsuits by commercial or academic clients to Indiana University for failure to comply with confidentiality requirements (work in GTTL is generally under CDA and MTA). 5. Lawsuits by patients or family due to harm resulting from inaccurate testing results. 6. Sanctions placed on Indiana University by the US FDA or other government agencies. 7. Loss of clients and NIH contracts or other grant support. 8. FDA or other government sanctions are public knowledge leading to negative press coverage of Indiana University.
Bachelor's degree in science or health-related field and one year of laboratory experience.
Proficient communication skills. Maintains a high degree of professionalism. Demonstrated time management and priority setting skills. Demonstrates a high commitment to quality. Possesses flexibility to work in a fast paced, dynamic environment. Highly thorough and dependable.
Three years of laboratory experience including GxP (GMP, GLP, GTP, CLIA or CAP) compliant laboratory experience.
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
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.