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 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

Imagine having the opportunity to develop a completely new therapeutic area, serving patients with limited treatment options in highly unmet medical needs. Imagine developing those therapeutics and serving those patients in an environment that is fundamentally science-first, data-driven, and relentless in serving patients. Then imagine being able to build capabilities, infrastructure, teams, and truly differentiated manufacturing processes from the ground up. Finally, imagine doing that, and within the same organization, walking across the hallway and immediately exploring a new product's safety and benefit in patients.

The Duchossois Family Institute (DFI) at the University of Chicago seeks a Quality Assurance Specialist for our current Good Manufacturing Practices (cGMP) facility. This facility will be 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 QA Specialist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility. This individual will be responsible for ensuring that manufactured products meet standards of quality, reliability, and safety.

Responsibilities

• Oversee the electronic Documentation, Change Control and Training system.

• Implement the Quality Management System (QMS) for the organization.

• Manage and oversee equipment installation and calibration activities.

• Establish Standard Operating Procedures (SOPs) and specifications for various quality and manufacturing processes.

• Collaborate with the purchasing / inventory specialist to ensure raw materials from external suppliers meet quality requirements.

• Manage incoming inspection of raw material for cGMP use.

• Establish Vendor score cards and perform supplier audits for critical vendors.

• Review Production Batch Records and manage disposition of material at each step of the manufacturing process.

• Collect, compile, and analyze relevant quality data and obtain information regarding quality performance.

• Manage non-conformance reports (NCRs) and trend non-conforming data regarding product and processes.

• Conduct quality control tests / inspections to verify quality of incoming material and finished goods.

• Review existing processes, specifications, and documents and identify improvement opportunities as seen fit.

• Supports data collection and analytical needs of research projects. Conducts literature reviews and helps write reports and manuscripts. Ensures project compliance with different policies, procedures, directives, and mandates.

• Takes responsibility for the following non-laboratory duties: transcribing and coding data; developing data collection instruments; presenting research; and recruiting and scheduling research subjects. Acquires higher-level skills and knowledge in the process.

• Takes responsibility for the following laboratory duties: recognizing abnormal results and varying conditions or procedures to correct problems; setting up and performing experiments. Analyze the meaning, significance, causes, and effects of the subject.

• 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 2-5 years of work experience in a related job discipline.

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Certifications

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Preferred Qualifications

Education

• Bachelor's degree in business management or administration, Biology or Bioengineering or related fields.

Experience

• Previous quality assurance role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.

• Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.

Preferred Competencies

• Excellent organizational and communication skills, with a mindset on driving quality-oriented activities.

• Strong analytical and problem-solving skills.

• Strong ability to collaborate with cross-functional teams.

Working Conditions

• Office Setting Environment.

• Laboratory environment.

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

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

No

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

Staff 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.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

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.

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