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Bio-Manufacturing Scientist

University of Chicago

University of Chicago

This job is no longer accepting applications

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Chicago, IL, USA
Posted on Friday, September 22, 2023

Department

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.


Job Summary

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-manufacturing Scientist for our current Good Manufacturing Practice (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 a 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-Manufacturing Scientist is responsible for all aspects of microbiome drug substance and drug products process development that will take place within the DFI cGMP Facility. This individual will be responsible for designing and optimizing the anaerobic microbiome culturing, Fermentation, Purification, Lyophilization, Encapsulation, and Cryopreservation processes for ongoing early-stage development of Live Biotherapeutic Products (LBPs) manufacturing.

Responsibilities

  • Develop scalable anaerobic fermentation cultures including inoculum ratio and feeding strategies.

  • 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.

  • Develop the scale up lyophilization, encapsulation and cryopreservation processes for anaerobic bacteria strains in anaerobic environments.

  • Perform routine maintenance of lab equipment.

  • Establish in-process QC testing and inspection such as bacterial 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 that supports QA, QC, and regulatory requirements.

  • Collect, compile, and analyze relevant manufacturing data and drive process improvement activities.

  • Review existing processes, specifications, and documents to identify improvement opportunities.

  • 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.


Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • B.S. degree in Microbiology, Biochemical Engineering, Bioengineering, or related field.

  • M.S. degree.

Experience:

  • 5+ years of previous Bio-processing Engineering/Bio-manufacturing experience in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.

  • Experience with bacterial cell culturing, fermentation, and purification (Tangential Flow Filtration) for anaerobic bacteria strains is desirable.

  • Experience with anaerobic culturing is desirable.

  • Experience with lyophilization, encapsulation and cryopreservation for anaerobic bacteria strains is desirable.

  • Experience with bottling, sealing, and labeling of drug products.

  • Hands-on experience in performing laboratory 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.

Preferred Competencies

  • 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.

Working Conditions

  • Office Setting Environment.

  • Laboratory/cleanroom environment.

Application Documents

  • Resume (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

Research


Role Impact

Individual Contributor


FLSA Status

Exempt


Pay Frequency

Monthly


Scheduled Weekly Hours

40


Benefits Eligible

Yes


Drug Test Required

No


Health Screen Required

Yes


Motor Vehicle Record Inquiry Required

No


Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or 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 Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

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: http://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.

This job is no longer accepting applications

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