Patricia Gallagher

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.

Experience

1. Director of Quality Control

   Coimmune, Inc

   Jan 2022 — Present · 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

  1979 — 1981

• The University of North Carolina at Chapel Hill

  PhD, Biochemistry and Molecular Biology

  1986 — 1992