Associate, Manufacturing Operations

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

Benefits offered by this job

Overtime eligible

Annual discretionary bonus

Equity opportunities

Robust health coverage options

FSA/HSA options

Company-paid basic dental and vision

Lifestyle spending account

401(k) retirement plan

Up to 160 hours PTO per year (prorated

Job summary

Abeona Therapeutics Inc. is seeking an Associate I, Manufacturing (Manufacturing Operations) to join our Cleveland-based team. This full-time, on-site role supports manufacturing initiatives across multiple product pipelines, including cell therapies, in a fast-paced cGMP environment.

You will execute master production records, assist in equipment maintenance, and contribute to process optimization while upholding safety and quality standards to deliver high-quality therapies to patients.

Qualifications

• Bachelor's degree or equivalent in scientific discipline.
• General biological lab experience.
• Strong communication and interpersonal skills.
• Mammalian and/or insect cell culture experience and aseptic technique preferred.
• Experience with production processes for cell therapies or vaccines preferred.
• GXP, ISO, and FDA regulations knowledge preferred.
• Experience with Microsoft Office.

Responsibilities

• Support production of cell therapies in a cGMP facility with MPRs.
• Assist in equipment PMs per procedures.
• Execute studies to support process optimization and validation.
• Maintain regulatory compliance through accurate documentation.
• Collect and organize manufacturing data.
• Collaborate effectively while maintaining independent critical thinking.
• Demonstrate strong organizational skills and teamwork.
• Uphold EH&S policies and assist lab infrastructure safety.
• Perform additional duties as assigned by manager.

Skills

Biology lab exp

Cell culture experience

Interpersonal skills

Team collaboration

Communication skills

Education

Bachelor's degree in scientific discipline

Tools

MS Office

Job description

Join us as a Associate I, Manufacturing (Manufacturing Operations)!

Join Abeona Therapeutics as a Associate I, Manufacturing (Manufacturing Operations) in our Manufacturing department and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Abeona Therapeutics Inc.: Who We Are

Our Values: Patient First | Innovation | Integrity | Determination | Trust

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.

Your day-to-day as a Associate I, Manufacturing (Manufacturing Operations)

The Associate I role will be responsible for Manufacturing initiatives supporting multiple product pipelines. This role is an integral part of a fast-paced group responsible for the manufacture of retroviral vectors, autologous gene-corrected cell therapies, and other cGMP products. Responsibilities will include executing master production records and protocols as well as manufacturing commercial and clinical material across multiple products as well as supporting process optimization work and document generation. The candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture techniques as well as collaborative work in a team is an integral part of this position.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Schedule

This role is based at our Cleveland facilities and is full-time on site. The general working hours for this role are Sunday to Wednesday (10-hour shifts) from 8:00 a.m. to 6:30 p.m. (with some late night or weekend work on occasion). Initial training schedules may vary.

Does this sound like you?

To thrive as a Associate I, Manufacturing (Manufacturing Operations), the right combination of experience, education, skills, and attitude is essential.

A science background, a love of the lab, and a sharp eye for detail. You may be early in your career with general biology lab experience, and ideally some hands-on mammalian or insect cell culture and aseptic technique. Exposure to cell therapy, vector, or vaccine production and to GXP, ISO, and FDA regulations gives you a head start. You're a clear communicator and a collaborative team player who follows master production records with precision, thinks critically, stays organized in a fast-paced cleanroom, and puts safety and quality first. Most of all, you're energized by knowing your work helps bring gene-based therapies to the patients who need them.

Essential Responsibilities and Duties

• Support production of cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
• Assist in equipment PMs per established procedures.
• 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.

Required Qualifications

The background, knowledge, and skills required to be successful in the role are:

• Bachelor's degree or equivalent in scientific discipline, 0 to 2 years of related experience.
• General biological lab experience
• Must have 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.

Compensation and Benefits

• The anticipated base salary range for this position is $65,000 - $68,000 (Actual compensation will depend on experience and qualifications)
• Overtime eligible
• Annual discretionary bonus
• Equity opportunities
• Robust health coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account (wellness reimbursements)
• 401(k) retirement plan
• Up to 160 hours of paid time off accrual per calendar year (prorated based on date of hire)

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 accommodation 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 a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is required. May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.