Quality Control Analyst II; QC Analytical - 2ND SHIFT

Quality Control Analyst II (QC Analytical) - 2ND SHIFT (4PM-12AM)

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.

Company Description

Abeona Therapeutics Inc. is a commercial‑stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell‑based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno‑associated virus (AAV)‑based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.

The Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture‑based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need).

• Performs other duties as assigned by management.
• Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
• Train new employees on Quality Control process flows and testing methods.
• Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs).
• Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods.
• Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP).
• Provides input to improving QC systems and procedures to improve GMP compliance.
• Proactively communicates laboratory issues to supervisor or manager.
• Supports laboratory investigations related to test failures, discrepancies and deviations.
• Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc.

• BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 years of relevant experience.
• Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
• Experience in cell culture, immunostaining, and drug product potency testing preferred.
• Experience with DEV, CAPA and CR management preferred.
• Understanding of basic scientific concepts in one or more areas above.
• Experience with relevant analytical lab equipment and computers preferred.
• Good mathematical and organizational skills
• Ability to interact constructively with co‑workers to solve problems and complete tasks
• Some weekend work or late nights may be required periodically.

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 accommodations 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 lifting up to 20 pounds is required.

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account

Visa Sponsorship Not Currently Available

IMPORTANT:
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.

Mid‑Senior level

Full‑time

Quality Assurance