Overview:
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.
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.
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
Education:
Advanced degree in Pharmaceutical Sciences, Microbiology, Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline preferred.
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.
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.
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.
If you are a dynamic leader with a passion in the microbiome space and want to make an impact to human health and wellness, we invite you to apply for the Clinical Manufacturing Operations Director position.
Job Type: Full-time
Pay: From $135,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Ability to Commute:
- Chicago, IL 60637 (Required)
Ability to Relocate:
- Chicago, IL 60637: Relocate before starting work (Required)
Willingness to travel:
Work Location: In person