Abeona
Associate Director, Quality Control
Abeona, Cleveland, Ohio, us, 44101
The Associate Director Quality Control (QC) will lead QC activities associated with the GMP production. Such products include Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring and overall support for clinical and commercial product manufacturing.
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
Planning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete
Responsibility for ensuring 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 co-ordination of 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
Other activities as may be assigned
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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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
Planning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete
Responsibility for ensuring 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 co-ordination of 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
Other activities as may be assigned
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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