Department
 

BSD DFI - Staff

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 that will lead to therapies that increase resistance to a wide range of diseases.

Job Summary
 

The Clinical Manufacturing Operations Director supervises and manages a manufacturing production team consisting of microbiome process associates and assistants, a quality assurance professional, and bioengineers responsible for performing technical laboratory procedures to support biomanufacturing of live biotherapeutics (LBPs) for early phase FDA-approved clinical trials. The ideal candidate will work with scientists, industry partners, and clinicians involved in highly innovative, translational, early-stage clinical investigations focusing on microbiome reconstitution/augmentation with lyophilized commensal bacterial strains in a range of clinical scenarios. The director will have accountability and responsibility to lead the end-to-end manufacturing process, consisting of key unit operations such as master cell banking, fermentation, harvest, lyophilization, and milling of LBPs. A key component of the role will be FDA documentation for GMP manufacturing, including authoring, reviewing, and approving batch production record and general suite/operational activity SOPs and supervising analytical biological assays to assess the stability and integrity of LBPs. In addition, the ideal candidate will be responsible for the optimization of lyophilization procedures for anaerobic bacterial strains, procedures for manufacturing LBP capsules, and documentation of product quality, purity and stability, as well as documentation of cGMP activities while consistently maintaining workplace safety by providing supervision and training for cGMP staff.

Responsibilities

Responsible for supervising and managing a team of professional staff who perform technical laboratory procedures to assure compliance in drug manufacturing processes.

Provides technical guidance to staff, colleagues, and clients.

Works directly with leaders, faculty, and clinical staff to prioritize facilities and equipment requirements for LBP manufacturing.

Develops goals and executes operating procedures, practices, and guidelines for all clinical manufacturing activities.

Executes a comprehensive GMP facility master plan to optimize resources.

Maintains all Engineering Standards for GMP facilities and manufacturing operations. Ensures appropriate Business Continuity Planning, Emergency Coordination and Risk Management procedures are in place.

Enforces policies and Standard Operating Procedures (SOPs) for equipment and facility calibration and maintenance.

Ensures proper biological and safety protocols are followed to maintain compliance with equipment, facility, and asset management infrastructure. Reviews facility technical documentation in support of regulatory submissions.

Oversees the investigations of facility, equipment, and process deviations for the development of corrective actions to prevent re-occurrences and change management for any changes to qualified systems and process equipment in order to maintain equipment, facility and systems in a validated state.

Acts as a liaison with regulatory agencies (e.g., FDA) and community officials.

Manages maintenance records for equipment, facility, and systems is to keep operations optimized.

Hires and establishes performance expectations for staff members. Coaches staff on proper training, performance, and professional development.

Actively promotes safety rules and awareness by demonstrating good safety practices at all times including appropriate use of protective equipment.

Reports and takes initiative to correct safety and environmental hazards.

Manages the administration of the database(s) and subscribers, including the team's installation and maintenance of hardware and software.

Manages user support. Ensures that the team provides prompt and effective answers and issue resolutions to incoming questions.

Perform 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 7+ years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications
 

Education:

Advanced degree in Pharmaceutical Sciences, Microbiology, Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.

Experience:

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

Hands on experience with GMP manufacturing and/or bioprocess development related to live biotherapeutic processes.

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

Prior experience in Microbiology including familiarity with Bacterial Culturing, Culture Media Preparation and Selection, Bacterial Viability and Stability Determination and ability to interpret data resulting from a range of Bacterial Functional Assays.

Prior experience in developing lyophilized LBPs or biologic formulations.

Preferred Competencies

Demonstration of a high degree of flexibility, adaptability, and a willingness to learn and being both the ‘coach and player’ on the field.

Excellent organizational and communication skills, with a mindset of driving performance and innovation in a lean and highly effective team setting.

Strong analytical and problem-solving skills.

Strong team building, mentoring, leadership, or management experience.

Working Conditions

Onsite, regular attendance.

GMP facility, laboratory environment.

Must have physical ability to move compressed gas cylinders.

Occasional weekend/evening hours necessary to complete time-sensitive projects.

Application Documents

Resume (required)

Cover Letter (required)

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
 

People Manager

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.

 

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.