Associate, Manufacturing Operations

Abeona Therapeutics • Cleveland, OH

3d • Onsite

About The Position

The Associate I, Manufacturing role supports manufacturing initiatives across multiple product pipelines at Abeona Therapeutics. The position is part of a fast-paced team manufacturing retroviral vectors, autologous gene-corrected cell therapies, and other cGMP products. The Associate executes master production records and protocols, manufactures commercial and clinical material, supports process optimization, and generates documentation. The role requires experience producing biologics in a controlled cGXP setting, with strong aseptic and cell culture techniques and the ability to collaborate effectively. The work contributes to the quality and reliability of gene-based therapies in a compliance-focused environment.

This full-time, on-site position is based at the company's Cleveland facilities. General hours are Sunday through Wednesday, 8:00 a.m. to 6:30 p.m. (10-hour shifts), with occasional late-night or weekend work. Initial training schedules may vary.

Requirements

• Bachelor's degree or equivalent in a scientific discipline.
• 0 to 2 years of related experience.
• General biological laboratory experience.
• Strong communication and interpersonal skills.
• Experience with Microsoft Office.
• Ability to work as part of a team and maintain strong organizational skills.

Nice To Haves

• Mammalian and/or insect cell culture experience and knowledge of aseptic technique.
• Experience with production processes for cell therapies and/or viral vectors or vaccines.
• Working knowledge of GXP, ISO, and FDA regulations.

Responsibilities

• Support production of cell therapies in a cGMP facility in conjunction with manufacturing production records (MPRs).
• Assist with equipment preventive maintenance (PMs) according to established procedures.
• Execute studies, as directed, to support process optimization and validation.
• Maintain accurate documentation to ensure compliance with cGXP, FDA, and quality-system requirements.
• Collect and organize manufacturing data.
• Collaborate with others while applying independent and critical thought.
• Maintain compliance with EH&S policies and procedures and contribute to safety and laboratory infrastructure activities.
• Perform additional duties or responsibilities as assigned by the manager.

Benefits

• Overtime eligibility.
• Annual discretionary bonus.
• Equity opportunities.
• Robust health coverage options.
• FSA/HSA options.
• Company-paid basic dental and vision plans.
• Lifestyle spending account with wellness reimbursements.
• 401(k) retirement plan.
• Up to 160 hours of paid time off accrual per calendar year, prorated based on date of hire.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level