Princy Merlin Gmp

WORK HISTORY

EDUCATION

ABOUT PRINCY MERLIN GMP

With over 13 years of experience in GMP manufacturing, molecular biology, and clinical research, I have contributed to cell and gene therapy advancements in both academic and industry settings. My expertise spans gene editing (CRISPR-Cas9), iPSC reprogramming, T-cell immunotherapy, and molecular analysis (qPCR, ddPCR, flow cytometry, ELISA), with a strong focus on clinical and preclinical research.I have worked in clinical trial environments, supporting the development of T-cell-based immunotherapies, regenerative medicine applications, and patient-derived cell models. At Triumvira Immunologics, I contributed to T-cell therapy research, while at CCRM, I played a key role in iPSC-based regenerative medicine projects and Gene Editing Projects, including differentiation into pancreatic cells and large-scale cell banking.Beyond the lab, I have extensive experience in GMP documentation, compliance, and process optimization to ensure the quality and scalability of biomanufacturing. Additionally, I have mentored scientists, managed lab operations, and contributed to 9 peer-reviewed publications in oncology and regenerative medicine. Key Skills & Expertise: Clinical Research & Clinical Trials (Oncology, Immunotherapy, Regenerative Medicine and Cell and Gene Therapy) Regulatory Compliance & (GCP, TCPS-2, Health Canada, ICH-GCP, FDA, FACT, Tri- Council, GMP/ GLP, Batch Records, CAPA, Root cause Investigation, SOP, ELN,) Regulatory Documentation (Batch Records, CAPA, Root cause Investigation, SOP, ELN, Master Control QMS, Air table) Project Management (Asana, Kanban, Visio, Lean Six Sigma Gene Editing (CRISPR-Cas9), iPSC Reprogramming, T- cell Immunotherapy, Cancer Research GMP Manufacturing & Process Optimization Molecular & Analytical Techniques (qPCR, ddPCR, Flow Cytometry, Genomic Analysis, ELISA, Seq) Cell based and Functional assays Data Analysis, Scientific Writing Technology transfer, Training and MentorshipI am passionate about bridging research and clinical applications to drive innovation in cell and gene therapy. Let’s connect and collaborate!