Biomanufacturing Lead Scientist

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
 

The Duchossois Family Institute (DFI) at the University of Chicago seeks a Biomanufacturing Lead Scientist for our current Good Manufacturing Practice (cGMP) facility. This facility is 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 Biomanufacturing Lead 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.

• 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.

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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, Chemistry, Biology, or related field.

Experience:

• Thorough understanding of microbial fermentation processes and underlying microbial physiology.

• Experience in Bio-processing Engineering / Bio-manufacturing 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.

 

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