Leads process improvement and assay development and implementation in accordance with all applicable government regulations. Responsible for reporting, creating/developing standard operating procedures (SOP), and overseeing training of laboratory technicians on new and existing assays
The Indiana University Gene Therapy Testing laboratory (GTTL) analyzes samples from products manufactured at 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) the national gene therapy landscape and to remain competitive IU 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. This position will be required to coordinate testing with contract clients and, most importantly, insure timely tabulation and recording of GTTL is maintained to enable the Director to file monthly reports as required per government contracts. Testing in the GTTL requires strict adherence to government regulations as defined in CFR 21 under Good Manufacturing Practice (GMP) regulations and guidelines. The manager must author and maintain study agreements with each of the GTTL clients, review all worksheets and generate Final Reports for each agreement - all in compliance with Standard Operating Procedures and governmental regulations. The role is responsible for review and assistance with Root Cause Analysis for all Deviations and Out-of-Specifications following IU GTTL SOPs. She is responsible for working with the Director and the GTTL Quality Assurance Specialist in review of all SOPs and in participation in all audits by governmental agencies and clients. The NIH contract also requires the IU GTTL to develop novel GMP testing for emerging technology and the individual in this role will continue to assist the IU GTTL Director in publishing these important developments as in her prior publications.
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 a health-related field or biological sciences and five 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. Seeks to acquire knowledge in area of specialty. Highly thorough and dependable. Demonstrates a high level of accuracy, even under pressure. Articulate and responsive to colleagues.
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.