BSD DFI - cGMP
About the Department
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.
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.
- Designs and implements processes to optimize media and fermentation conditions for anaerobic bacteria strains to grow on large scale.
- Designs and leads the scale-up fermentation and purification processes for anaerobic bacteria strains in anaerobic environments.
- Establishes and optimizes scalable fermentation cultures including inoculum ratio and feeding strategies.
- Performs routine maintenance of lab equipment.
- Performs in-process QC testing and inspection such as Gram stain check and Yield check by CFU.
- Establishes Standard Operating Procedures (SOPs) and specifications for various manufacturing activities such as microbial Inoculum, Fermentation and Purification processes.
- Establishes Standard Operating Procedures (SOPs) and specifications for various equipment used for the production of Drug Substance and Drug Products.
- Maintains records of executed work and activities as outlined per Standard Operating Procedures and supports QA, QC and regulatory requirements.
- Collects, compiles, and analyzes relevant manufacturing data and drives process improvement activities.
- Reviews existing processes, specifications, and documents and identifies improvement opportunities as seen fit.
- Works closely with the Quality Assurance Specialist to ensure compliance with FDA and regulatory standards.
- Applies standard laboratory procedures to support clinical research studies, such as the preparation of reagents. Handles, processes, banks, and ships patient samples.
- Prepares quality and safety control measures for the laboratory, such as checks of equipment, temperature control, and documentation of quality improvement projects. Under a moderate degree of supervision, provides support to clinical research studies.
- Performs other related work as needed.
Minimum requirements include a college or university degree in related field.---
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.---
- B.S. degree in biochemical engineering, bioengineering, microbiology, biologics sciences or related fields.
- M.S. degree is highly preferred.
- 3+ 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.
- 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 manufacturing issues.
- Strong analytical and problem-solving skills.
- Strong ability to collaborate with cross functional teams.
- Office setting environment.
- Laboratory environment.
- Resume/CV (required)
- 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.Job Family
Individual ContributorFLSA Status
MonthlyScheduled Weekly Hours
YesRequires Compliance with University Covid-19 Vaccination Requirement
YesDrug Test Required
NoHealth Screen Required
YesMotor Vehicle Record Inquiry Required
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