Associate, Manufacturing Operations
About The Position
Abeona Therapeutics is seeking an Associate I, Manufacturing Operations to support manufacturing initiatives across multiple product pipelines. The role contributes to the manufacture of retroviral vectors, autologous gene-corrected cell therapies, and other cGMP products. It involves executing master production records and protocols, manufacturing commercial and clinical materials, supporting process optimization, and generating documents. The position requires experience in biologics production in a controlled cGXP environment, with strong aseptic and cell culture practices and the ability to work collaboratively in a team. The role is based at Abeona’s Cleveland facilities and is full-time onsite. The general schedule is Sunday through Wednesday, with 10-hour shifts from 8:00 a.m. to 6:30 p.m.; occasional late-night or weekend work may be required. Initial training schedules may vary. The work supports quality and regulatory compliance in the development and manufacture of gene-based therapies.
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 collaborate with others and work as part of a team.
- Strong organizational skills.
- Ability to work in a fast-paced cleanroom environment while following master production records precisely and prioritizing safety and quality.
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, in support of process optimization and validation.
- Maintain accurate documentation to support compliance with cGXP, FDA, and Quality Systems requirements.
- Collect and organize manufacturing data.
- Collaborate with others while applying independent and critical thinking.
- Maintain compliance with EH&S policies and procedures and contribute to activities that support safety and laboratory infrastructure.
- Perform additional duties or responsibilities as assigned by the manager.
Benefits
- Overtime eligible
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
