Director of Quality Control

3 weeks ago

Cleveland, Ohio, United States Abeona Full time
Job Summary

The Associate Director, Quality Control will lead QC activities associated with GMP production, including Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of QC Microbiology and Transport functions.

Key Responsibilities
  • Implement and manage a GMP compliant laboratory control program in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, methods, validation, and stability.
  • Plan and execute QC testing to ensure agreed-upon cycle times are met, associated records are evaluated, and data are accurate, valid, and complete.
  • Ensure completion of release testing of raw materials, process intermediates, packaging components, and drug products.
  • Maintain and trend environmental monitoring and personnel monitoring programs to ensure compliance to regulatory requirements.
  • Support CMO production activities by coordinating testing activities with appropriate external and in-house departments.
  • Support in-house production by coordinating in-process QC testing, environmental monitoring, and release/characterization testing with appropriate departments/CTOs.
  • Prepare specifications and Certificates of Analysis (COA) for QA review.
  • Establish and execute stability programs for raw materials, cell and viral banks, drug substances, and drug products.
  • Coordinate with the Analytical Methods Development group the phase-appropriate qualification/validation of microbiology procedures, the transfer of such procedures into QC Microbiology, and the setting of appropriate acceptance criteria.
  • Manage the development, validation, and approval of all microbiology and raw materials test methods used in production operations as well as Assay Transfer with external customers or CMO/CTOs.
  • Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs), and COAs.
  • Draft and review of SOPs, records/forms, and protocols for in-house QC testing and overall QC operations.
  • Assist in the preparation of CMC regulatory submissions.
  • Interact with the FDA and other worldwide regulatory agencies, per product filings (IND, BLA MAA, etc.), regarding any questions relating to microbiology, stability testing, and inspection of drug product.
  • Conduct investigations into atypical and out-of-specification test results internally and externally.
Requirements
  • A minimum of Bachelor's in Biological Sciences, Bioengineering, or Chemistry.
  • Minimum of 7 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic products.
  • Minimum of 3 years demonstrated track record of leadership and management of QC groups with people development and performance management skills.
  • In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validation.
  • Experience managing CMO/CTO relationships preferred.
  • Excellent interpersonal, organizational, and written/oral communication skills.

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