Patricia Gallagher
Director of Quality Control @Coimmune, Inc
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WORK HISTORY
Director of Quality Control @Coimmune, Inc
Durham, NC, US
Responsible for GMP Laboratory Operations for Cell Therapy Drug Responsible for method development of assays for transfer to QC including flow cytometry assays, nucleic acid techniques, and cytometric bead assays Participate in Process Development of Cell Therapy Products Completed in-house method validation for pharmaceutical safety test methods - Mycoplasma detection by DNA amplification techniques Rapid Sterility USP and USP Endotoxin Chromogenic Technique and Gel Clot Method USP and Contributed to CMC section of IND Submission Analytical Method Development, Qualification and Validation Analytical Procedures Justification of Specifications Batch Analysis Container Closure Integrity Testing Stability Summary and Stability Data Completed Comparability Protocol, Execution, and Report for Cell Therapy Drug Product (ICH Q5E)
EDUCATION
Penn State University
Bachelor of Science (BS), Biochemistry and Molecular Biology
The University of North Carolina at Chapel Hill
PhD, Biochemistry and Molecular Biology
ABOUT PATRICIA GALLAGHER
Proven leader with a strong background in biotechnology and pharmaceutical field with over 13+ years of GMP knowledge/experience.Solid background and emphasis in Manufacturing Sciences and Technology, Laboratory Systems, Analytics, and R&D. Consistently exceeded company goals and expectations. Professional experience in biologics, cell therapy, Analytical Method Development, Process Development, Equipment Commissioning and Validation, Quality Systems, start up, and Departmental Budgets.
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