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:

• 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.
• GXP experience.

Other 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.