Director, GMP Facility for Live Biotherapeutic Product Manufacturing at The University of Chicago in Chicago, Illinois

Posted in Other 4 days ago.





Job Description:

Department



BSD DIV - Duchossois Family Institute: Staff



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



The job manages a team of professional staff responsible for scientific research projects and research facilities. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives, and mandates. Manages the production of articles, reports, and manuscripts, and presents research findings at meetings and/ or conferences.


The Duchossois Family Institute (DFI) at the University of Chicago seeks a Director for our current Good Manufacturing Practices (cGMP) facility. The DFI's goal is to optimize or augment microbiome functions that enhance disease resistance. We are seeking an individual to direct the production of Live Biotherapeutic Products (LBP) for early phase clinical trials in the newly established DFI cGMP facility. The DFI cGMP Director will recruit and supervise the LBP production team, including Manufacturing Scientists, Bioprocess Engineers and Microbiome Process Technicians. The Director will interact with scientists and clinicians involved in clinical studies focusing on microbiome reconstitution/augmentation with lyophilized commensal bacterial strains in a range of clinical scenarios. The Director will oversee the Master Cell Bank and the fermentation, harvest, lyophilization and milling of LBPs and will author media/buffer production and general suite/operational activity SOPs. The Director will supervise analytical assays to assess stability and integrity of LBPs and will be responsible for optimization of lyophilization procedures for anaerobic bacterial strains, procedures for manufacturing LBP capsules and documentation of product quality, purity and stability. The Director will document cGMP activities, maintain workplace safety and provide direction and training for cGMP staff.



Responsibilities



  • Develops and maintains standards for all major GMP equipment and manufacturing operations. Ensures that appropriate Emergency Coordination and Risk Management procedures are in place.

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

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

  • Acts as a liaison with regulatory agencies (e. g., FDA, EMA, EPA, OSHA) and community officials relative to utilities, worker safety, waste removal, permitting, licensing, validation and commissioning of operations. Addresses inquiries by government agencies in a timely manner.

  • Directs and supervises staff responsible for facility maintenance, process reliability and automation.

  • Hires staff members and establishes performance expectations. Coaches staff on specific performance and professional development issues. Implements proper training and formal performance management.

  • Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

  • Develop and implement programs on cGMP initiatives to improve quality.

  • Assist in strategic and operational quality planning.

  • Assist in the introduction, development, implementation of periodic updates in the QA procedures, manual, objectives, and philosophies.

  • Provide direction and coordination of cGMP quality improvement activities utilizing continuous quality improvement principles and methodologies.

  • Educate and train employees with their impact in the cGMP quality management system.

  • Participate in internal and external cGMP quality audits.

  • Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.

  • Interface with supplier cGMP quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

  • Manages research professionals and support staff involved with planning, monitoring, and compliance aspects of research projects. Advises other researchers on long-range plans for research projects.

  • Develops goals and operating procedures, practices, and guidelines for research activity based on department strategy.


  • Manages the laboratory facilities, including the purchase of new equipment and the maintenance and repair of laboratory equipment.


  • Reviews research of others, and may conduct own research, in area of expertise. Edits and approves articles, reports and manuscripts. Presents research findings at meetings and/or conference. Manages the research of processes in clinical or non-clinical settings. Program and use computers to store, process, and analyze data.


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

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Certifications:





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Preferred Qualifications




Education:



  • PhD in Pharmaceutical Sciences, Microbiology, Chemical Engineering, or related discipline.





Experience:



  • Understanding of GMPs and regulatory expectations related to live biotherapeutic drug manufacturing processes.

  • Prior experience in developing lyophilized LBPs or biologic formulations.

  • Excellent organizational and communication skills.

  • Strong analytical and problem-solving skills.

  • Previous mentoring, leadership, or management experience




Preferred Competencies



  • Experience in biotech engineering/manufacturing environment.

  • Expertise in live biotherapeutic product (LBP) development, quality control, and production.

  • Minimum of 2 years of experience in a functional leadership position within one or more areas including Process Engineering, Facilities/Engineering Maintenance, Automation, Validation or related functions.

  • Demonstrated leadership skills in directing facilities and process support of cGMP manufacturing operations.

  • Experience managing multiple engineering disciplines and knowledge related to reviewing and approving construction designs, utilities management, maintenance, calibration, equipment installation and specifications.

  • Skilled at managing the services of external contractors.

  • Experience supporting manufacturing facilities and utility systems within an FDA regulated environment.

  • Thorough understanding of cGMP related to Facility design and operation, equipment, utility and cleanroom design operation and maintenance.

  • Extensive knowledge of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing.

  • Strong interpersonal and communications skills and ability to present to clients and senior management.

  • Project Management knowledge.

  • Excellent supervisory and management skills.

  • Expertise in regulatory compliance for all IND and SOPs per FDA standards.




Working Conditions



  • Laboratory environment

  • Must have physical ability to move compressed gas cylinders




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



People Manager



FLSA Status



Exempt



Pay Frequency



Monthly



Scheduled
Weekly Hours



40



Benefits Eligible



Yes



COVID-19 Vaccination or Approved Medical or Religious Exemption Required



Yes



Drug Test Required



No



Health Screen Required



Yes



Motor Vehicle Record Inquiry Required



No



Posting Statement



Effective October 15, 2021, the University of Chicago requires COVID vaccination for all students, faculty, and staff members. Individuals may claim exemption from the vaccine requirement for medical or religious reasons.


The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected 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.
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