Microbiome Quality Control Associate

University of Chicago • Chicago, IL

2d • Onsite

About The Position

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. The cGMP facility is the 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 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 <61>/<62>, and media production, 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.

Requirements

• A college or university degree in related field.
• 2-5 years of work experience in a related job discipline.
• Excellent written and verbal communication skills.
• Strong analytical, mathematical, and problem-solving skills.
• Exceptional multi-tasking 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 cGMP / cleanroom environment for extended periods of time.
• Cleanliness, organization, good laboratory skills, excellent record keeping, and Good Documentation Practices (GDP).
• Knowledge of regulatory policies and procedures.

Nice To Haves

• 2+ 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.
• In-depth hands-on experience with USP<61> and USP<62> quality control releasing testing for pharmaceutical products.
• In-depth hand on experience with Environmental Monitoring (EM) of viable and non-viable sampling.
• Experience with anaerobic culturing is desirable.
• Understanding microbial fermentation processes and underlying microbial physiology.
• Hands-on experience with Vaporized Hydrogen Peroxide (VHP systems).
• Hands-on experience in performing laboratory experiments and operating laboratory equipment.

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.
• 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.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees