The Senior Research Coordinator will lead activities in developing the clinical manufacturing processes and analytical methods for generating human cellular and gene therapy products for use in pre-clinical and/or clinical Phase I/II trials. It is critical that this position develop robust procedures that will comply with current Good Manufacturing Practice (cGMP) requirements and with FDA and State regulations, including the production of sterile drug products, to ensure the safety of patients receiving these products in clinical trials. The Senior Research Coordinator must be able to translate processes from a research environment to a highly regulated environment with manufacturing occurring in ISO 7 certified cleanrooms and ISO 5 certified biological safety cabinets. Independently, or with minimal supervision, the incumbent will be responsible to plan and execute process and assay development, process characterization, qualification and validation studies. This person will work in a team environment and lead process development activities as well as prepare study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials.
Bachelor of Science in biology, engineering, or a related discipline and three years of lab experience.
Combinations of education and related experience may be considered.
Experience with aseptic technique. Ability to perform short and long-term project planning in terms of the generation of scope of work documents and project plans, resource demands, timelines, and budget forecasting. Knowledge of safety, quality systems and quality assurance concepts. Experience with authorship of technical reports, grant writing, or regulatory submissions. Excellent organizational skills and ability to manage multiple projects. Strong interpersonal, communication and problem solving skills as well as ability to work effectively in cross-functional teams.
PhD. Experience with bioreactor operations and process scale-up and scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies.
Salary Plan: PAE
Salary Grade: 3RS
Campus: IUPUI - Indianapolis
Department: MEDICAL & MOLECULAR GENETICS (IN-MMGE-IUINA)
Internal Number: 77870
About Indiana University
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.