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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

We are seeking a Microbiome Production Technician for our current Good Manufacturing Practices (cGMP) facility. This facility is 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 senior Production Associates.
• Perform routine maintenance of lab equipment including setup, cleaning, and appropriate care.
• Perform in-process QC testing for drug substance and drug products.
• Maintain the highest standards of laboratory workplace safety and product quality.
• Meet 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.
• 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 control measures for the laboratory.
• 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 ---

Certifications:

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Preferred Qualifications

Education:

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

Experience:

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

Pref rred Competencies

• Strong analytical and problem-solving skills.
• 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.
• Laboratory environment.

Application Documents

• Resume (required)
• Cover Letter (preferred)

When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

FLSA Status

Non-Exempt

Pay Frequency

Biweekly