Kyle Moritzkat

About Kyle Moritzkat

Experienced Leader with a demonstrated history of working in the medical and biotech industries. Skilled in regulatory affairs, laboratory management, method development, qualification, validation, project management, quality assurance, and regulatory guidance relating to medical devices, biologics, and AAV gene therapy. Strong professional with experience leading cross-functional teams in pre-clinical, R&D, AD, PD, GMP, and clinical settings.

Experience

1. Director, Analytical Cmc

   GEMMA Biotherapeutics

   Feb 2025 — Present · King of Prussia, PA, US

   Lead cross-functional teams to define and execute strategic imperatives for novel therapeutics to meet regulatory and operational goals~ Author CMC Module 3 sections for global IND and IMPD submissions, and provided critical input, data, and reports to support briefing books for pre-IND and Type C meetings with Health Authorities~ Develop and implement regulatory compliant strategies that align with global requirements for AAV gene therapy-based products~ Serve as CMC subject matter expert with during audits, inspections, and IND/BLA filings, contributing to successful outcomes~ Collaborate with global regulatory teams to address Health Authority inquiries, audit findings, and provide comprehensive technical documentation for submissions~ Solve technical challenges involving analytical failures, leveraging deep scientific knowledge and innovative thinking~ Establish new technologies and methodologies to test products and/or analyze results based upon industry trends and scientific literature~ Develop and maintain analytical CMC timelines and budgets across 10+ product portfolios, directly supporting IND/BLA enabling projects~ Engage with contract organizations, technology vendors, and external partners to ensure successful technology transfer and qualification/validation activities~ Effectively communicate complex technical concepts to non-technical stakeholders to align regulatory priorities, ensuring clear communication of key milestones and challenges~ Manage 30+ concurrent stability study programs for key biologics assets including plasmids, cell banks, reference standards, Toxicology, Pilot, and GMP drug substance and drug product, and diluents, including authoring of protocols and reports, managing timepoint pulls, deviations, and expiry extension~ Track and trend analytical data for in-process, batch release, and stability testing~ Author specification and justification of specification documents and lead monthly specification committee meetings

Education

• Marywood University

  Bachelor of Science (BS), Environmental Science

  2009 — 2013

• University of Pennsylvania

  Master of Regulatory Affairs, Regulatory Affairs

Skills

• Environmental Science
• Environmental Education
• Environmental Issues
• Environmental Awareness
• Environmental Policy
• Arcgis
• Biology
• Data Collection
• Environmental Compliance
• Gis
• Hazardous Waste Management
• Report Writing
• Sustainability
• Laboratory
• Microbiology
• Customer Service
• Microsoft Office
• Microsoft Excel
• Microsoft Outlook
• Microsoft Powerpoint
• Technical Writing
• Data Analysis
• Data Entry
• Documentation
• Quality Control
• Laboratory Information Management System (Lims)