This Process Development Laboratory Specialist will focus on process development and process characterization for manufacturing stem cells and other cellular biologics, at pilot and bioreactor scale, and downstream processing. He/she will be responsible for development and execution of protocols for manufacturing of human cellular 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 Process Development Laboratory Specialist 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. He/she will be responsible for cell processing, process scale-up/scale-down, bioreactor process parameters, cryopreservation, packaging and biobanking. Under minimal supervision, he/she will be expected to assist the PI in designing and performing experiments, organize and carefully document results, analyze and interoperate results, and communicate findings. This position will collaborate with the PI in writing of Standard Operating Procedures and Validation Plans, and in performing technology transfer of procedures for Cell and Gene Therapy Manufacturing clinical trials.
Bachelor of Science (BS) or Bachelor of Arts (BA) degree in biology, engineering, or a related discipline and one year of laboratory experience.
Experience in aseptic and/or cell-culture operations. Experience with cell-based assays (ELISA, FACS, immunofluorescence). Excellent organizational skills and ability to manage multiple projects. Strong interpersonal, communication, and problem solving skills as well as demonstrated ability to work effectively in cross-functional teams. Flexibility in working schedule to accommodate weekend or off-hours work.
Master of Science (MS) degree. Experience with bioreactor operations and process scale-up. Experience or working knowledge of FDA regulations and Good Manufacturing Practices. Experience in the creation and revision of Standard Operating Procedures (SOPs).
Working Conditions / Demands
Must be able to perform essential functions with or without an accommodation.
Salary Plan: TE
Salary Grade: SR1
Job Function: Health Services
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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
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 .
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at firstname.lastname@example.org or by visiting IUPD.
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.