Job Description:

• 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.

Preferred Qualifications

Education:

• B.S. degree in Biochemical Engineering, Bioengineering, Microbiology, Biologics Sciences or related fields.

• M.S. degree is strongly preferred.

Experience:

• 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.

â‹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)

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.

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