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, that there is no indication of adverse events related to the molecular therapy, and move testing services to the next phase. Trains and leads junior-level staff.
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. The applicant will participate in cell-culture based, ELISA and molecular assays (digital droplet PCR, Southern Blot, qPCR).
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 IU GTTL also 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). We are partially funded through a NIH contract which also requires development of testing for the emerging gene therapy 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.
Bachelor's degree in science or a health-related field and three years of GxP (GMP, GLP, GTP, CLIA or CAP) compliant 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. Possesses a high degree of initiative. Ability to build strong customer relationships.
Master's degree and five years of 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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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 .
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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.