• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $105,000 - $126,600

Position Summary

The Columbia Initiative in Cell Engineering and Therapy (CICET) cGMP Facility Operations Manager will oversee the evaluation, implementation and maintenance of all GMP laboratory equipment, instruments and systems. Reporting to the Director of the CICET Core Facilities, the cGMP Facility Operations Manager will work closely with CUIMC and NYPH Facilities Departments, CICET leadership, and external vendors. In this role, the cGMP Facility Operations Manager will ensure proper maintenance of all areas and timely progression of CICET cell and vector GMP production projects, as well as maintain clear and open lines of communication.

Responsibilities

The cGMP Facilities Operations Manager is responsible for overseeing the launch and maintenance of facilities and equipment supporting CICET cell and vector production activities. Responsibilities include equipment selection, validation, 24/7 maintenance, support of day-to-day GMP facility operations, managing vendor agreements, handling facility or system emergencies, and participating in discussions regarding construction-related projects. Addresses and responds to escalated issues as needed. The cGMP Facilities Operations Manager oversees the facility in all matters concerning housekeeping support services, HVAC, electrical, engineering, waste management, painting, leaks, grounds, fire safety, pest control, signage, repairs/maintenance, plumbing, locksmith, and carpentry.

Operations

• Assist GMP CICET Core Facility Director and QA Associate Director to:
  • Prepare, launch, and maintain the CICET GMP facility
  • Order, install, and IQ/OQ equipment/instruments/systems (including 24/7 monitoring systems) in the CICET GMP facility
  • Validate the CICET GMP facility
  • Help draft and revise GMP facility SOPs
  • Help new projects to be onboarded in the GMP facility
  • Ensure GMP readiness of the cell processing and vector room and GMP production
• Be responsible for the following cGMP facility operations
  • User access to and orientation of the facility
  • Keeping the cGMP facility and operation in compliance; ensures that inspections are current
  • Maintenance and calibration of the cGMP facility and equipment
  • Equipment/instrument calibration database update and maintenance
  • Schedules and supervises third-party vendor work; ensures proper signage for all GMP spaces are maintained
  • Provide facility maps of bench/desk and storage areas
  • Maintaining the GMP facility functionality and event alarm system
  • Ordering and maintaining GMP production supplies, gowning supplies, cleaning detergents, and UV system
  • Facility sanitization
  • Preventive maintenance scheduling and conducting environmental monitoring, and CAPA if needed
  • Provide up-to-date detergent log-books and room log-books
  • Ensure that the facility is ready for third-party and regulatory inspections
  • Supervises and ensures timely response to emergency and unusual service calls (including after hours); evaluates the urgency and prioritizes accordingly.
  • Facility operation-related training, including GMP gowning certification 

• Works with the Director of CICET Core Facilities and QA Associate Director to ensure coordination with Columbia University Public Safety and Environmental Health Safety to address all security and safety issues related to the cGMP facility.

• Works with the Assistant Director for Manufacturing Operations and Process Development to schedule clinical production in the GMP facility

• Ensures that GMP-grade/GMP-compatible raw materials are available for scheduled cell and vector production

• Attends meetings with Columbia University Facilities senior management staff, as needed.

• Keep abreast of pertinent literature and technologies, especially regulations and GMP guidelines issued by FDA and NIH

Finance

• Participates in the development of annual personnel/direct expense budgets.
• Investigates and implement ways to control operating expenses

Project Management

• Coordinates services for construction/renovation projects including scheduling and supervision of project team.
• Participates in and contributes to facilities projects as assigned. Executes project tasks and mitigates any issues as needed.
• Assists with monthly and ad-hoc facility reports and dashboards.
• Coordinates the GMP production and Engineering/Validation runs for IND-enabling studies.

Strategy

• Monitors effectiveness and ensures staff are prepared and support mechanisms are in place. Supports strategy for expansion as needed.
• Ensure consistent communication throughout the GMP facility and that feedback channels are in place. Works with staff leads to address any escalated concerns and identify risks as needed.

Minimum Qualifications

• Bachelor’s degree in Biotechnology, Bioengineering, or related field or equivalent 
• Minimum of 4 years of related experience in laboratory facilities and operations management in an academic environment
• Ability to work independently to complete tasks and collaboratively with multiple teams to execute CICET strategic activities
• Demonstrated proficiency in problem assessment, resolution, and collaborative problem-solving in complex, and interdisciplinary settings.
• Excellent organizational skills, time management, and the ability to set priorities among multiple competing objectives, tasks, and initiatives are required.
• Basic project management skills including planning and executing technical and operational project activities with cross-functional teams.

Preferred Qualifications

• Advanced degree in a relevant scientific discipline. 
• 7 years of experience in laboratory facilities and operations management in an academic environment
• Experience with academic or industry GMP manufacturing. 
• Strong leadership skills with experience in team management and development. 
• Demonstrated ability to work collaboratively with academic and regulatory teams.

Other Requirements

• Successful completion of applicable compliance and systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.