Facilities Manager

Facilities Manager

Abeona Therapeutics

Full-time | Cleveland, Ohio | United States

JOB DESCRIPTION

Our Values : Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics , we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Company Description

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.

Role Description

This is a full-time, on-site role for a Facilities Manager located in Cleveland, OH. The Facilities Manager will oversee the day-to-day operations of the company's facilities, including offices, laboratories, cGMP-compliant Manufacturing, and all support areas. This position coordinates maintenance and repairs of HVAC, electrical, plumbing and utility systems with scheduled manufacturing campaigns, equipment calibration / qualification activities and metrology. This position also provides broad support for facilities construction and upgrades, ensuring a safe, efficient, and well-maintained environment. Responsibilities include managing maintenance staff, coordinating facility repairs, ensuring compliance with safety regulations, and overseeing vendor contracts and budgets. The role also involves monitoring building systems and equipment, planning and coordinating facility upgrades, and managing space allocation. After hours availability will be required.

Essential Duties and Responsibilities

• Ensure maintenance activities are performed in accordance with cGMP requirements and Abeona SOPs.
• Coordinates maintenance activities with third parties.
• Executes preventative maintenance activities for systems at Abeona facilities.
• Oversee and support actions to troubleshoot, repair, maintain, calibrate, test, and replace equipment and components for systems such as : Utility supplies (gas, electrical), HVAC, chillers, air compressors, boilers, ISO classified clean rooms, and exhaust equipment.
• Maintains accurate and up-to-date documentation including drawings, contracts, procedures, etc.
• Maintain facility records and communicate changes in facility plans across departments.
• Create and revise SOPs related to the facilities' equipment.
• Assist Operations and Quality departments with change control processes related to existing qualified and validated facilities.
• Provides support to the commissioning process of new facilities and utilities.
• Plan, monitor and schedule facility modifications with the Facility Coordinator.
• Support the Facility Coordinator in the design and development of building spaces and layouts.
• Oversee and support actions to troubleshoot, repair, maintain, calibrate, test, and replace equipment and components for systems such as : Utility supplies (gas, electrical), HVAC, chillers, air compressors, boilers, ISO classified clean rooms, and exhaust equipment.
• Other duties as assigned.

Qualifications

Physical Demands

Benefits

Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes :

Visa Sponsorship Not Currently Available

IMPORTANT : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Visa Sponsorship Not Currently Available

IMPORTANT : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.