Department
About the Department
Job Summary
Responsibilities
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.
Provides training and supervision of junior level technicians.
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.---
Work Experience:
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Certifications:
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Preferred Qualifications
Education:
B.S. degree in Biochemical Engineering, Bioengineering, Microbiology, Biological Sciences or related field.
Experience:
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.
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
Role Impact
FLSA Status
Pay Frequency
Scheduled Weekly Hours
Benefits Eligible
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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.
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