Rx Group
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Direct message the job poster from Rx Group
Founder at Rx Group
Helping biotech’s bring safer medicines to patients, by finding them the best quality assurance talent. 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 of 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 products. The 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 high‑throughput commercial manufacturing and 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.
Ensure the successful and timely completion of all lot release and stability testing to support all of Abeona’s products.
Evaluate, review, and approve assay development and qualification reports to ensure smooth and efficient transfer of analytical test methods to the Quality Control group.
Build and manage 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.
Generate and manage 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.
Provide strategic leadership and oversight for all quality control activities related to cell and gene therapy products, including testing, release, and stability.
Propose expansions to corporate capabilities, requiring knowledge and experience with Assay Development, Analytical Quality Control, Quality Control Microbiology (EM/PM and utilities monitoring), and Quality Control Raw Materials Testing.
Demonstrate strong technical knowledge in all areas of cell and gene therapy testing—data analysis, laboratory testing, cell culture, bioassay testing, and laboratory investigations.
Identify and evaluate new scientific approaches or methods to improve the products/processes of Abeona.
Communicate clearly and effectively, both in writing and verbally.
Show 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 a Bachelor’s degree in Biological Sciences, Bioengineering, Chemistry, or a related field.
15 or more years of experience in the biotechnology or pharmaceutical industry, primarily focused on analytical Quality Control and Assay Development.
Experience managing and directing commercial cGMP analytical testing laboratories, including testing and releasing Gene Therapy products.
5+ years of demonstrated leadership and management of QC groups, with strong people‑development and performance‑management skills.
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 technology 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 and problem‑solving skills.
Demonstrated experience managing a budget and headcount plan.
Excellent interpersonal, organizational, and communication skills.
If you are interested in applying to this position, please contact Hemish Ilangaratne at h.ilangaratne@rx-group.io or apply directly to this advert.
#J-18808-Ljbffr
Direct message the job poster from Rx Group
Founder at Rx Group
Helping biotech’s bring safer medicines to patients, by finding them the best quality assurance talent. 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 of 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 products. The 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 high‑throughput commercial manufacturing and 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.
Ensure the successful and timely completion of all lot release and stability testing to support all of Abeona’s products.
Evaluate, review, and approve assay development and qualification reports to ensure smooth and efficient transfer of analytical test methods to the Quality Control group.
Build and manage 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.
Generate and manage 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.
Provide strategic leadership and oversight for all quality control activities related to cell and gene therapy products, including testing, release, and stability.
Propose expansions to corporate capabilities, requiring knowledge and experience with Assay Development, Analytical Quality Control, Quality Control Microbiology (EM/PM and utilities monitoring), and Quality Control Raw Materials Testing.
Demonstrate strong technical knowledge in all areas of cell and gene therapy testing—data analysis, laboratory testing, cell culture, bioassay testing, and laboratory investigations.
Identify and evaluate new scientific approaches or methods to improve the products/processes of Abeona.
Communicate clearly and effectively, both in writing and verbally.
Show 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 a Bachelor’s degree in Biological Sciences, Bioengineering, Chemistry, or a related field.
15 or more years of experience in the biotechnology or pharmaceutical industry, primarily focused on analytical Quality Control and Assay Development.
Experience managing and directing commercial cGMP analytical testing laboratories, including testing and releasing Gene Therapy products.
5+ years of demonstrated leadership and management of QC groups, with strong people‑development and performance‑management skills.
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 technology 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 and problem‑solving skills.
Demonstrated experience managing a budget and headcount plan.
Excellent interpersonal, organizational, and communication skills.
If you are interested in applying to this position, please contact Hemish Ilangaratne at h.ilangaratne@rx-group.io or apply directly to this advert.
#J-18808-Ljbffr