Process Development Laboratory Specialist

MEDICAL & MOLECULAR GENETICS (IN-MMGE-IUINA)

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).

Must be able to perform essential functions with or without an accommodation.

IUPUI campus

Indianapolis, Indiana

Salary Plan: TE

Salary Grade: SR1

FLSA: Nonexempt

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.

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