Clinical Manufacturing Operations Director - Chicago, United States - The University of Chicago

The University of Chicago
The University of Chicago
Verified Company
Chicago, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description
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


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 reoccurrences 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.

  • Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

  • Certifications:
  • 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)

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 Requi
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