Associate Director, Quality Control

2 weeks ago

Cleveland, United States Abeona Full time

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 stabilityPlanning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and completeResponsibility for ensuring completion of release testing of raw materials, process intermediates, packaging components, and drug productsMaintain and trend environmental monitoring and personnel monitoring programs to ensure compliance to regulatory requirementsSupport CMO production activities by coordinating testing activities with appropriate external and in-house departmentsSupport in-house production by co-ordination of in-process QC testing, environmental monitoring, and release/characterization testing with appropriate departments/CTOsPrepare specifications and Certificates of Analysis (COA) for QA reviewEstablish and execute stability programs for raw materials, cell and viral banks, drug substances and drug productsCoordinate 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 criteriaManage 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/CTOsOversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAsDraft and review of SOPs, records/forms and protocols for in-house QC testing and overall QC operationsAssist in the preparation of CMC regulatory submissionsInteract 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 productConduct investigations into atypical and out-of-specification test results internally and externallyOther activities as may be assignedRequirements A minimum of Bachelor's in Biological Sciences, Bioengineering or ChemistryMinimum of 7 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic productsMinimum of 3 years demonstrated track record of leadership and management of QC groups with people development and performance management skillsIn-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validationExperience managing CMO/CTO relationships preferredExcellent interpersonal, organizational, and written/oral communication skills

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