Bio-processing Engineer for Live Biotherapeutic Products (LBPs) Manufacturing
University of Chicago
The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground that will lead to therapies that increase resistance to a wide range of diseases.
About the Department
Imagine having the opportunity to develop a completely new therapeutic area, serving patients with limited treatment options in highly unmet medical needs. Imagine developing those therapeutics and serving those patients in an environment that is fundamentally science-first, data-driven, and relentless in serving patients. Then imagine being able to build capabilities, infrastructure, teams, and truly differentiated manufacturing processes from the ground up. Finally, imagine doing that, and within the same organization, walking across the hallway and immediately exploring a new product’s safety and benefit in patients.
The Duchossois Family Institute (DFI) at the University of Chicago seeks a Bio-Processing Engineer for our current Good Manufacturing Practices (cGMP) facility. This facility will be a first of its kind, state-of-the art, adaptable microbiome manufacturing center embedded at the interface of a world-class microbiome sciences research team and patient-centric medical center aimed at translating innovation at the bench to investigations in the clinic. Our objective is to embed a biotech, product development focused capability within an advanced academic research environment, all towards driving value for patients in addressing unmet medical needs in record time. The DFI’s goal is to optimize or augment microbiome functions that enhance disease resistance. The Bio-Processing Engineer is responsible for all aspects of microbiome drug substance process development that will take place within the DFI cGMP Facility. This individual will be responsible for designing and optimizing the microbial Inoculum, Fermentation and Purification processes for ongoing early-stage development of Live Biotherapeutic Products (LBPs) manufacturing.
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.
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.
Education:Minimum requirements include a college or university degree in related field.
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)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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