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 Microbiome Production Associate 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 Microbiome Production Associate is responsible for all manufacturing aspects of microbiome drug substance and drug products that will take place within the DFI cGMP Facility. This individual will perform daily manufacturing activities which include but not limited to Fermentation, Purification, Lyophilization, Encapsulation and Cryopreservation for ongoing early-stage development of Live Biotherapeutic Products (LBPs) manufacturing.

Responsibilities

• Perform hands-on operations for Fermentation, Purification, Lyophilization, Encapsulation and Cryopreservation of LBPs under the guidance of Bio-process Engineers.

• Perform routine maintenance of lab equipment including setup, cleaning, and appropriate care of equipment.

• Perform in-process QC testing for drug substance and drug products.

• Maintain the highest standards of laboratory workplace safety and product quality.

• Meeting all training requirements for applicable Standard Operating Procedures (SOPs).

• Maintain records of executed work and activities as outlined per Standard Operating Procedures and support QA, QC, and regulatory requirements.

• Documentation of all manufacturing activities in batch records, logs and forms.

• Follow verbal and written instructions and procedures for processes and equipment.

• Identify and report non-conforming events in a timely manner.

• Comply with regulations set forth in SOPs.

• 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 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 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Technical Degree in Chemical engineering or related field.

• B.S. degree in Chemical engineering or Biology is highly preferred.

Experience:

• 3+ years of previous hands-on manufacturing experience in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.

• Hands-on experience operating laboratory equipment is highly desirable. This includes operation of anaerobic chambers, bioreactors / fermenters, tangential flow filtration and lyophilization equipment.

​Preferred Competencies

• Strong analytical and problem-solving skills.

• Ability to work independently with minor supervision.

• Ability to work with others in a collaborative team environment.

• Regular and reliable performance, attendance and work ethics.

• Ability to work in cGMP/cleanroom environment for extended periods of time.

• Cleanliness, organization, good laboratory skills, excellent record keeping, and Good Documentation Practices (GDP).

Working Conditions

• Office environment.

• Lab environment.

Application Documents

• Resume (required)

• Cover Letter (preferred)

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 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 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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