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
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
Project Management
Strategy
Minimum Qualifications
Preferred Qualifications
Other Requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Title | Grade | Design Template | Requisition Identifier | City | State | Country | Location | Department | Category | Summary | Employment Type | Level |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Variable Hours Officer | Grade 105 | 549994 | Columbia University Medical Center | New York | United States | Columbia University Medical Center | Obstetrics and Gynecology | Administrative Support, General Administration | Reporting to the Department Administrator with accountability to the Vice Chair for Education/Program Director, develop and implement policies to be in compliance with ACGME/RRC guidelines such as Accreditation Data System (ADS), milestones, simul... | Part Time | ||
Assistant Director, Compliance | Grade 13 | 549961 | Morningside | New York | United States | Morningside | Finance and Administration | Finance/Accounting | The Assistant Director for Compliance will oversee, manage, and lead compliance efforts across Columbia University’s campuses and properties, including Morningside, Bakers Field, Residential, and Manhattanville. This role ensures the safety and re... | Full Time | ||
Phlebotomy Operations Manager | Grade 105 | 549892 | New York | New York | United States | New York | Faculty Practice Organization | Health/Clinical | The Phlebotomy Operations Manager supervises the activities of the outpatient central draw station located at 1111 Westchester Avenue. This central draw station primarily supports the Columbia University Faculty Practice physicians located at 1111... | Full Time |
Wait! Before you go, are you interested in a career at Columbia University? Sign up here!
Thank you, for sharing your information. A member of our team will reach out to you soon!
This website uses cookies as well as similar tools and technologies to understand visitors' experiences. By continuing to use this website, you consent to Columbia University's usage of cookies and similar technologies, in accordance with the Columbia University Website Cookie Notice.