Microbiome Production Technician

Department

BSD DFI - cGMP

The Duchossois Family Institute (DFI) at the University of Chicago is at the forefront of microbiome research, leveraging advanced technologies in newly established, state-of-the-art facilities to accelerate 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, pioneering therapies that harness the microbiome – revolutionizing the prevention and treatment of a wide range of diseases.

This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

We are seeking a Microbiome Production Technician for our current Good Manufacturing Practices (cGMP) facility. This facility represents a first-of-its-kind, state-of-the-art, adaptable microbiome biomanufacturing center strategically embedded at the interface of a world-class microbiome sciences research team and a patient-centric medical center. Its mission is to translate bench innovations into clinical investigations. Our objective is to embed a focused biotech product development capability within an advanced academic research environment, with the goal of driving patient value by addressing unmet medical needs in record time.

The DFI’s goal is to optimize or augment microbiome functions that enhance disease resistance. This role supports the production and quality control testing of drug substance and drug products that are manufactured at the DFI cGMP Facility. Additionally, this position also contributes to research efforts, aiding in the advancement of Live Biotherapeutic Products from development all the way through production.

• Partner with the bioprocessing team to define and characterize live biotherapeutic products (LBPs) for scalable production within a cGMP biomanufacturing facility.
• Assist in optimizing media formulation and fermentation conditions for various anaerobic bacteria.
• Help refine fermentation parameters to enhance LBP yield and viability.
• Help identify harvest conditions that maximize viability and stability of LBPs.
• Perform rigorous Quality Control (QC) testing, including CFU counts, USP compendial tests, for drug substance and drug products.
• Conduct biomanufacturing operations – including environmental monitoring, media production, fermentation, tangential filtration, lyophilization, encapsulation, and facility cleaning - in a cGMP cleanroom environment.
• Operate and maintain specialized laboratory equipment under guidance from senior Production associates such as Anaerobic chambers, Biological safety cabinets, Bioreactors/fermenters, Tangential flow filtration systems, Lyophilization system, MALDI Biotyper, spectrophotometers, and pH meters.
• Perform routine cleaning, proper setup, care, and preventive maintenance of all laboratory equipment.
• Perform hands-on biomanufacturing operations for fermentation, purification, lyophilization, encapsulation and cryopreservation of LBPs under guidance from senior Production associates.
• Maintain the highest standards of laboratory workplace safety, quality, and cGMP compliance.
• Complete all training requirements for applicable Standard Operating Procedures (SOPs).
• Meticulously record executed work in batch records, logs, and forms as outlined per established SOPs.
• Support QA, QC, and regulatory documentation and audit requirements.
• Follow all verbal and written instructions and procedures for processes and equipment.
• Identify and report non-conforming events promptly.
• Consistently comply with SOPs and regulatory guidelines.
• Conducts new tests and researches on new technologies for implementation in the laboratory. Solves routine or standard problems relating to the collection and management of patient results and data.
• Has general awareness of safety, quality control, and quality assurance procedures. Maintains quality and safety…