Sr. Specialist I, Quality Assurance - Quality Operations

About Abeona

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.

Position Overview

TheSenior Specialist I, Quality Assurance performs routine activities associated with the development of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position will provide Quality oversight and support for Assay Development, Process Development, Design Control, R&D, Validation, continuous improvement initiatives, and life cycle management projects. The successful candidate will bring a strong understanding of cGMP, Quality Systems, and regulatory expectations within the cell and gene therapy space. The Senior Specialist I, Quality Assurance will report to the Associate Manager, Quality Assurance or above and will support Assay Development, Process Development, Validation, and R&D as the functional group QualityAssurance representative.

Essential Duties and Responsibilities

• Review and Approvals:
  • Study protocols and summary reports for Assay Development, Process Development, and Validation activities.
  • Validation documentation (IOQ, IOPQ, Commissioning, OQ, etc.).
  • Method qualification / validation protocols and reports and ensure resolution of and discrepancies that occurred during execution.
• Quality Oversight:
  • new method development and method bridging activities.
  • design control elements, including risk management and design verification/validation documentation.
• Support continuous improvement initiatives across QA and cross-functional teams, contributing to system and process enhancements.
• Ensure Quality compliance in life cycle management projects by reviewing changes, assessing impact, and participating in cross-functional reviews.
• GDP - Document Controls:
  • Process document control requests and issue-controlled forms, logbooks, notebooks, master production records, labels, and protocols.
  • Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols.
  • Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
  • Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, Development Reports, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
• Site Collaboration:
  • Collaborate with R&D, Manufacturing, QC, and Regulatory Affairs to ensure Quality is integrated early in development stages.
  • Support site inspections and inspection readiness activities.
• Personal Development
  • Enhance skills via regular training and continuing education, including professional society membership/participation.
• Perform other duties as required.

Qualifications

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 5 years of experience in quality assurance or quality engineering in a pharmaceutical, biotech, biologics, or medical device cGMP regulated manufacturing environment preferred.
• Knowledge of FDA and EU regulations, ICH guidelines, and cGMP/cGTP requirements.
• Experience supporting Design Control and product development processes.

Preferred Qualifications or Experience:

• Ideal candidate will have a strong scientific background. Advanced degree within a life science or engineering field is preferred. Ideal candidate will have lab bench experience.

Other required competencies:

• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management, and work independently with scientific and/or technical personnel. .
• Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

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 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.

Benefits

Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes:

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account
• PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
• Compensation (annual): $80,000.00 to $96,800.00 (Compensation range includes base salary plus anticipated annual bonus)

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.

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.