Associate, Manufacturing Operations

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

Abeona is looking for a Manufacturing Associate to join our team in Cleveland, OH. The successful candidate will be responsible for Manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector, autologous gene-corrected cell therapies, and clinical AAV gene therapies. Responsibilities will include executing protocols and manufacturing clinical material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position.

Essential Duties and Responsibilities

• Produce cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
• Execute studies in support of process optimization and validation.
• Author, review, and provide technical support for manufacturing SOPs and MPRs.
• Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
• Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
• Strong organizational skills required.
• Must be able to work as part of a team.
• Contribute to activities that support safety and/or lab infrastructure.

Qualifications

• Previous GXP experience.
• BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience.
• General biological lab experience.
• Experience with mammalian and/or insect cell culture technology.
• Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
• A strong background in the fundamentals and scale-up of production of biologic molecules strongly preferred.
• Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.

Additional Desired Skills and Abilities:

• Advanced communication and organizational skills.
• Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
• Attention to detail and accuracy.
• Detailed record keeping and data documentation.
• Demonstrated project management skills.
• Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
• Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines.
• High level of proficiency with Microsoft Office programs.
• Less than 10% travel. Any travel will be reimbursed in accordance with company policy

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required.

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): $70,000 - $$73,700 (please note that this range includes annual salary and the maximum anticipated annual bonus)

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.