Senior Director, Quality Control

Rx Group is partnered exclusively with Abeona Therapeutics to lead the search for a Senior Director, Quality Control (on-site, Cleveland, OH).

Abeona is now transitioning into full commercial operations following FDA approval of its lead autologous cell therapy, ZEVASKYN. This role will lead all Quality Control functions - shaping QC strategy, systems, and teams as the company scales post-approval.

Senior Director, QC

The Sr. Director Quality Control (QC) will lead Assay Development and Quality Control activities associated with the GMP production of cell and gene therapy products. Such products include Adeno-associated Viral Vectors (AAV),Retroviral Cell Therapy Vectors and autologous cell and gene therapy drug product. This position will oversee the operation of the Assay Development and Quality Control functions. The ideal candidate will be highly skilled in managing an integrated testing schedule that supports both a high-throughput commercial manufacturing. Additionally, the Senior Director will possess superior technical, problem solving, and mentoring skills that facilitate team and individual development.

Responsibilities:

• Provide strategic and operational leadership to the Quality Control department responsible for performing testing for drug substance and an autologous drug product.
• Ensuring the successful and timely completion of all lot release and stability testing to support all of Abeona's products.
• Evaluating, reviewing, and approving assay development and qualification reports to ensure smooth and efficient transfer of analytical test methods to the Quality Control group.
• Building and managing an appropriate qualification/requalification program to ensure all analysts executing QC testing are fully trained and current on all aspects of their assigned analytical testing areas.
• Work collaboratively with cross-functional teams, including manufacturing, supply chain, and quality assurance, to support the overall quality of cell therapy products.
• Generating and managing monthly and quarterly metrics (KPIs) to track QC analytical testing performance.
• Frequently update stakeholders on trends and implement corrective action plans.
• Provide subject matter expertise when engaging in various discussions with external regulatory agencies.
• Providing strategic leadership and oversight for all quality control activities related to cell and gene therapy products, including testing, release, and stability
• Additionally, proposed expansions to corporate capabilities will require knowledge and experience with Assay Development, Anlytical Quality Control, Quality Control Microbiology (EM/PM and utilities monitoring) and Quality Control Raw Materials Testing.
• Strong technical knowledge in all areas of cell and gene therapy testing is a must. Areas of expertise must including data analysis, laboratory testing, cell culture, bioassay testing and laboratory investigations.
• Identifies and evaluates new scientific approaches or methods to improve the products/processes of Abeona
• Strong written and oral communication skills are a must.
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including contract testing laboratories. .

Requirements

• Minimum of Bachelor's in Biological Sciences, Bioengineering, Chemistry or relevant field
• 15 or more years of experience in the biotechnology or pharma industry with a primary focus on analytical Qualiyt Control and Assay Development
• Experience managing/directing commercial cGMP analytical testing laboratories with experience testing and releasing Gene Therapy products
• 5+ years demonstrated track record of leadership and management of QC groups with people development and performance management skills
• Additionally, we are looking for an individual with at least fifteen years of experience managing/directing cGMP analytical testing laboratories with a minimum of five to eight years of experience testing and releasing Gene Therapy products
• In-depth experience of QC analytical methods and requirements for biologic product testing and method validation
• Deep expertise in molecular, biochemical, and cell-based assay technologies
• Oversee assay tech transfer to internal or external partners.
• Stay current with regulatory guidance and emerging assay technologies; drive innovation and continuous improvement within the analytical function.
• Exceptional analytical thinking skills and problem-solving skills
• Demonstrated experience managing a budget and headcount plan
• Excellent interpersonal, organizational, and written/oral communication skills

If you are interested in applying to this position, please contact Hemish Ilangaratne at h.- or apply directly to this advert.