Job Description

Job Description

Job Description

About Abeona

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.

Position Overview

The Facilities Manager provides technical support for the smooth and efficient operation of Abeona 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.

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 changes at 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

• Bachelor's degree (preferred) or equivalent work experience, with at least 3 years' experience in construction management and/or maintenance of buildings encompassing manufacturing, laboratory and office facilities, preferably with 2 or more years and with facilities operating in a cGMP environment.
• Excels at Operations of Facilities.
• Solid project management skills with respect to planning, tracking, prioritization, and timelines, with a hands-on approach.
• Excellent written and oral communication and presentation skills. · Fluent in English (oral and written). Note: The required time of relevant experience is a guideline only. That is, quality of work and level of responsibility taken on weigh heavily in determining the appropriate level for an Abeona employee.)

Physical Demands

Regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 50 pounds is required. On-call availability for occasional nights or weekends is a must.

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:

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account
• Compensation (annual): $103,500 - $109,250

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.

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