Microbiome Quality Control Associate
University of Chicago, Chicago, IL, United States
About the Department
The Duchossois Family Institute (DFI) at the University of Chicago is using cutting‑edge technologies and developing facilities to accelerate clinical research and introduce novel interventions that optimize microbiome‑mediated host defenses, with the goal of enhancing human health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground in therapies that will increase resistance to a wide range of diseases.
Job Summary
The Microbiome Quality Control Associate will support our bioprocessing operations for our current Good Manufacturing Practices (cGMP) facility. This individual will perform routine Quality Control testing that includes CFU viability, USP / media production, and other assays for both Drug Substance and Drug Product forms of Live Biotherapeutic Products (LBPs). In addition, they will serve as the key trainer for Quality Control testing, ensuring consistent performance of testing, and will support both research and development efforts as well as finished goods production of LBPs.
Responsibilities
Conduct Quality Control testing and documentation for drug substance and products in a cGMP environment.
Lead and support training for Quality Control related activities and ensure SOP compliance.
Perform end‑to‑end biomanufacturing processes for live biotherapeutic products (fermentation through final formulation).
Collaborate on process development, optimization, and scale‑up of live biotherapeutic production, including media and fermentation improvements.
Operate, maintain, and troubleshoot laboratory and cleanroom equipment and facilities.
Support environmental monitoring, investigations (deviation/OOS), and non‑conforming reporting.
Maintain strict adherence to safety, regulatory standards, and quality assurance practices.
Perform equipment maintenance, sterilization, and cleanroom decontamination procedures.
Review manufacturing activities and ensure accurate implementation of procedures and documentation.
Apply standard laboratory procedures to support clinical research studies, such as the preparation of reagents, handling, processing, banking, and shipping of patient samples.
Prepare quality and safety control measures for the laboratory, including checks of equipment, temperature control, and documentation of quality improvement projects. Provide support to clinical research studies under a moderate degree of supervision.
Perform other related work as needed.
Education and Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through 2–5 years of work experience in a related discipline.
Preferred Qualifications
2+ years of previous hands‑on manufacturing experience in biopharmaceutical development or manufacturing, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Hands‑on experience operating laboratory equipment, including anaerobic chambers, bioreactors/fermenters, tangential flow filtration, and lyophilization equipment.
In‑depth experience with USP and USP quality control releasing testing for pharmaceutical products.
In‑depth experience with Environmental Monitoring (EM) of viable and non‑viable sampling.
Experience with anaerobic culturing.
Understanding of microbial fermentation processes and underlying microbial physiology.
Hands‑on experience with Vaporized Hydrogen Peroxide (VHP) systems.
Hands‑on experience performing laboratory experiments and operating laboratory equipment.
Preferred Competencies
Excellent written and verbal communication skills.
Strong analytical, mathematical, and problem‑solving skills.
Exceptional multitasking and time‑management skills.
Exceptional record‑keeping, organizational skills, and meticulous attention to detail.
Mature, reliable, and professional demeanor.
Ability to work independently with minor supervision.
Ability to work collaboratively within a team.
Adaptable to changing working situations and assignments.
Ability to train others.
Ability to work in a cGMP/cleanroom environment for extended periods of time.
Cleanliness, organization, good laboratory skills, and Good Documentation Practices (GDP).
Knowledge of regulatory policies and procedures.
Working Conditions
Laboratory environment.
Physically capable of moving, connecting, and disconnecting gas cylinders.
Compensation
$60,000.00 – $75,000.00
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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. 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.
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The Duchossois Family Institute (DFI) at the University of Chicago is using cutting‑edge technologies and developing facilities to accelerate clinical research and introduce novel interventions that optimize microbiome‑mediated host defenses, with the goal of enhancing human health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground in therapies that will increase resistance to a wide range of diseases.
Job Summary
The Microbiome Quality Control Associate will support our bioprocessing operations for our current Good Manufacturing Practices (cGMP) facility. This individual will perform routine Quality Control testing that includes CFU viability, USP / media production, and other assays for both Drug Substance and Drug Product forms of Live Biotherapeutic Products (LBPs). In addition, they will serve as the key trainer for Quality Control testing, ensuring consistent performance of testing, and will support both research and development efforts as well as finished goods production of LBPs.
Responsibilities
Conduct Quality Control testing and documentation for drug substance and products in a cGMP environment.
Lead and support training for Quality Control related activities and ensure SOP compliance.
Perform end‑to‑end biomanufacturing processes for live biotherapeutic products (fermentation through final formulation).
Collaborate on process development, optimization, and scale‑up of live biotherapeutic production, including media and fermentation improvements.
Operate, maintain, and troubleshoot laboratory and cleanroom equipment and facilities.
Support environmental monitoring, investigations (deviation/OOS), and non‑conforming reporting.
Maintain strict adherence to safety, regulatory standards, and quality assurance practices.
Perform equipment maintenance, sterilization, and cleanroom decontamination procedures.
Review manufacturing activities and ensure accurate implementation of procedures and documentation.
Apply standard laboratory procedures to support clinical research studies, such as the preparation of reagents, handling, processing, banking, and shipping of patient samples.
Prepare quality and safety control measures for the laboratory, including checks of equipment, temperature control, and documentation of quality improvement projects. Provide support to clinical research studies under a moderate degree of supervision.
Perform other related work as needed.
Education and Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through 2–5 years of work experience in a related discipline.
Preferred Qualifications
2+ years of previous hands‑on manufacturing experience in biopharmaceutical development or manufacturing, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Hands‑on experience operating laboratory equipment, including anaerobic chambers, bioreactors/fermenters, tangential flow filtration, and lyophilization equipment.
In‑depth experience with USP and USP quality control releasing testing for pharmaceutical products.
In‑depth experience with Environmental Monitoring (EM) of viable and non‑viable sampling.
Experience with anaerobic culturing.
Understanding of microbial fermentation processes and underlying microbial physiology.
Hands‑on experience with Vaporized Hydrogen Peroxide (VHP) systems.
Hands‑on experience performing laboratory experiments and operating laboratory equipment.
Preferred Competencies
Excellent written and verbal communication skills.
Strong analytical, mathematical, and problem‑solving skills.
Exceptional multitasking and time‑management skills.
Exceptional record‑keeping, organizational skills, and meticulous attention to detail.
Mature, reliable, and professional demeanor.
Ability to work independently with minor supervision.
Ability to work collaboratively within a team.
Adaptable to changing working situations and assignments.
Ability to train others.
Ability to work in a cGMP/cleanroom environment for extended periods of time.
Cleanliness, organization, good laboratory skills, and Good Documentation Practices (GDP).
Knowledge of regulatory policies and procedures.
Working Conditions
Laboratory environment.
Physically capable of moving, connecting, and disconnecting gas cylinders.
Compensation
$60,000.00 – $75,000.00
Benefits
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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. 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.
#J-18808-Ljbffr