Associate, Manufacturing Operations

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.

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.

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.

The current manufacturing team schedule is Monday to Friday, from 8:30 AM – 5:00 PM, with occasional weekend shifts. The manufacturing team will be transitioning into a 4‑day work week with 10‑hour shifts in the near future. These days will be Sunday to Wednesday and Wednesday to Saturday, from 8:00 AM – 6:30 PM.

• 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.

• 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.
• Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.
• Previous GXP experience.
• 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.

• 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%…