Bio-processing Engineer for Live Biotherapeutic Products (LBPs) Manufacturing
University of Chicago (UC)
Location: Chicago, Illinois
Internal Number: JR24343
Location: Chicago, IL
Design and implement processes to optimize media and fermentation conditions for anaerobic bacteria strains to grow on large scale.
Design and lead the scale-up fermentation and purification processes for anaerobic bacteria strains in anaerobic environments.
Establish and optimize scalable fermentation cultures including inoculum ratio and feeding strategies.
Perform routine maintenance of lab equipment.
Perform in-process QC testing and inspection such as Gram stain check and Yield check by CFU.
Establish Standard Operating Procedures (SOPs) and specifications for various manufacturing activities such as microbial Inoculum, Fermentation and Purification processes.
Establish Standard Operating Procedures (SOPs) and specifications for various equipment used for the production of Drug Substance and Drug Products.Â
Maintain records of executed work and activities as outlined per Standard Operating Procedures and support QA, QC and regulatory requirements.
Collect, compile, and analyze relevant manufacturing data and drive process improvement activities.
Review existing processes, specifications, and documents and identify improvement opportunities as seen fit.
Work closely with Quality Assurance Specialist to ensure compliance with FDA and regulatory standards.
Develops new tests and evaluates new technology for implementation in diagnostic testing.
Prepares quality and safety control measures for the laboratory, such as checks of equipment, temperature control, and documentation of quality improvement projects. Under a limited degree of supervision, provides support to clinical research studies.
Performs other related work as needed.
B.S. degree in Biochemical Engineering, Bioengineering, Microbiology, Biologics Sciences or related fields.
M.S. degree is strongly preferred.
5+ years of previous Bio-processing Engineering experience in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Experience with Cell growth, Fermentation and Purification (Tangential Flow Filtration) for anaerobic bacteria strains is highly desirable.
Experience with anaerobic culturing is desirable.
Hands-on experience performing lab experiments and operating laboratory equipment.
Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics is a plus.
Excellent organizational and communication skills, with a mindset on solving complex biomanufacturing issues.
Strong analytical and problem-solving skills.
Strong ability to collaborate with cross-functional teams.
Office Setting Environment.
Cover Letter (preferred)
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.