Cell Therapy Manufacturing Associate — Onsite Cleveland | Equity

Abeona Therapeutics; Cleveland (OH); On-site; USD 65,000 - 68,000; Full time

Benefits offered by this job

Annual discretionary bonus

Equity opportunities

Robust health coverage options

FSA/HSA options

Company-paid basic dental and vision

Lifestyle spending account

Up to 160 hours of PTO per year

Job summary

Abeona Therapeutics in Cleveland, OH is seeking an Associate I, Manufacturing (Manufacturing Operations) to support manufacturing initiatives across multiple product pipelines in a cGMP setting. The role is full-time, on site, with a Sunday–Wednesday 10-hour shift schedule and occasional weekend work.

You will execute master production records, support process optimization, and help ensure quality and regulatory compliance.

Qualifications

• Bachelor's degree or equivalent in a scientific discipline, 0 to 2 years of related experience.
• General biological lab experience.
• Strong communication and interpersonal skills.
• Mammalian and/or insect cell culture experience and aseptic technique knowledge is highly preferred.
• Experience with production processes for cell therapies and/or vial vectors or vaccines is highly preferred.
• Working knowledge of GXP, ISO, and FDA regulations is preferred.
• Experience with Microsoft Office.

Responsibilities

• Support production of cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
• Execute studies (as directed) in support of process optimization and validation.
• Ensure regulatory compliance (cGXP, FDA, Quality Systems) by maintaining accurate documentation.
• Collect and organize manufacturing data.
• 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.
• Maintain compliance in EH&S policies and procedures and contribute to activities that support safety and/or lab infrastructure.
• Additional duties or responsibilities as assigned by manager.

Skills

Strong communication

Biological lab experience

Mammalian cell culture

Insect cell culture

GXP knowledge

ISO knowledge

FDA knowledge

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

Abeona Therapeutics in Cleveland, OH is seeking an Associate I, Manufacturing (Manufacturing Operations) to support manufacturing initiatives across multiple product pipelines in a cGMP setting. The role is full-time, on site, with a Sunday–Wednesday 10-hour shift schedule and occasional weekend work.

You will execute master production records, support process optimization, and help ensure quality and regulatory compliance.