Associate, Manufacturing Operations

Job Description

Job Description

Join us as a Manufacturing Associate I, Operations!

Join Abeona Therapeutics as a Manufacturing Associate I, Operations 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.

Work onsite Sunday to Wednesday (10-hour shifts) during and contribute to impactful products that change peoples' lives. With a competitive salary of $63,000 to $65,000 per year (with an annual discretionary bonus in addition to base salary), this position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment.

You will have options to participate in a comprehensive benefits program that includes options for Medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year.

Oh, and snacks! We have healthy snacks and beverages, as well as a few good, old-fashioned sweets, so that you can keep those energy levels up throughout the day.

Abeona Therapeutics Inc.: Who We Are

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

Join us in making cure the new standard of care. 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 Manufacturing Associate I, Operations

As a Manufacturing Associate I, Operations at Abeona Therapeutics, your day-to-day activities will focus on 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.

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

The usual working hours for this role are Sunday to Wednesday (10-hour shifts) from 8:00 AM to 6:30 PM (with some late night or weekend work on occasion).

Does this sound like you?

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

You may be a strong fit for this role if you are a detail-oriented, hands-on manufacturing professional who is energized by mission-driven work and committed to producing high-quality therapies for patients. You bring a strong scientific foundation, experience in controlled lab or cGXP environments, and a careful approach to aseptic technique, cell culture, documentation, and process execution. You work well in a collaborative, fast-paced setting, take ownership of your responsibilities, and stay focused on safety, compliance, accuracy, and continuous improvement.

Essential Responsibilities and Duties

• 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.

Required Qualifications

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

• 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 (GxP experience strongly preferred).
• 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.

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 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.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• 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.

Connect with our team today!

If you're ready to take your career to the next level and join a team that values hard work and changing lives - complete our application today!