Quality Control Analyst I (QC Analytical) - 2nd Shift (4PM - 12AM)

Abeona Therapeutics • Cleveland, OH

2d • Onsite

About The Position

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 The Quality Control Analyst I performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunostaining, protein characterization and product specific analytical test methods. Interacts with employees internal and external to Quality Control. Schedule: 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).

Requirements

• BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 1 to 3 years of relevant experience.
• Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
• Understanding of basic scientific concepts in one or more areas above.
• Good mathematical and organizational skills
• Ability to interact constructively with co-workers to solve problems and complete tasks
• 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.

Nice To Haves

• Experience in cell culture, qPCR and protein analysis preferred.
• Experience with relevant analytical lab equipment and computers preferred.

Responsibilities

• Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
• Train on applicable Standard Operating Procedures (SOPs) and Methods.
• Perform in-process and finished drug product analysis, using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.
• Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in 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.
• Initiates 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 usage and review, etc.
• Performs other duties as assigned by management.

Benefits

• 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): $63,525 - $76,230 (compensation includes anticipated annual bonus and also includes a 5% shift differential that begins once the employee transitions to the second shift hours)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees