Microbiome Quality Control Associate

Microbiome Quality Control Associate The University of Chicago - 4.0 Chicago, IL Job Details Full-time $60,000 - $75,000 a year 1 day ago Benefits Health insurance Paid time off Qualifications Record keeping Laboratory safety Laboratory equipment maintenance Process optimization Sterilization Pharmaceutical regulatory compliance Safety standards in production Laboratory experiments Process improvement Mid-level Laboratory staff training Manufacturing standard operating procedures Analysis skills Math Laboratory compliance management Laboratory quality control Pharmaceutical plant experience Organizational skills Media preparation Cleanroom Environmental monitoring Equipment maintenance Training & development Quality assurance within manufacturing Decontamination Training Research & development 2 years Communication skills Process engineering Full Job Description 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 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. 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 / , 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. 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.

Minimum Qualifications Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications Experience:

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 and USP 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. Preferred Competencies 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. Working Conditions Laboratory environment. Physically capable of moving, connecting, and disconnecting gas cylinders. 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 Scheduled Weekly Hours 40 Drug Test Required No Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay Rate Type Salary FLSA Status Exempt Pay Range $60,000.00 - $75,000.00 The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible Yes 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. 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. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.