Hasan Yildiz

About Hasan Yildiz

Product and process development; Cell & Gene Therapy, anti-sense oligonucleotide (ASO).• Formulation design, product development and support, controlled and sustained drug delivery systems.• Experienced working under GMP/ICH guidelines, and in GxP environment• Exceptional problem-solving skills with ability to prioritize in multi concurrent projects• Excellent team player and strong leadership and management skills.

Experience

1. Senior Scientist

   Novartis

   Jun 2020 — Present · Durham, NC, US

   Oversees complex cell and gene therapy drug product process development efforts as a technical lead within a cross-functional team• Leading early and late-stage projects within the drug product unit to enhance manufacturing gene therapy technologies, capabilities, and processes.• Technical SME for fill/finish technology transfer, drug device and manufacturing process technical support for both internally and externally produced pre-clinical and clinical cell and gene therapy products.• Designing and executing of in-house drug product-related experiments including particulate assesment, device compatibility, and other drug product studies.• Managing experimental activities at CDMOs including leachable/extractable studies, container closure studies, filtration development/validation, and other drug-product related studies/testing.• Reviewing and approving manufacturing documentation (batch records, SOPs, protocols) as needed.• Authoring and reviewing relevant drug product CMC sections for global regulatory submissions- collaborating with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidance.• Strong knowledge of all aspects of cell and gene therapy drug product development with applied experience in formulation design (DoE) and development.• Leading efforts to build a drug product lab to support new technology assessment around CAR-T therapy

Education

• Northeastern University

  PhD, Chemical engineering

  2008 — 2013

Skills

• Statistics
• Histology
• In Vivo
• Electron Paramagnetic Resonance (Epr)
• Frap
• Microscopy
• Matlab
• Confocal Microscopy
• Data Analysis
• Qrtpcr
• Bca Protein Assay
• Cell Culture
• Research
• Fluorescence Microscopy
• Pcr
• Elisa
• Cytotoxicity Assay
• Chemical Engineering
• Microbiology
• Cdna Synthesis
• Light-Sheet Microscopy
• Simulations
• Sem
• Materials Science
• Sds Page
• Nanotechnology
• Mathematical Modeling
• Multiple Particle Tracking
• Western Blotting
• Ex-Vivo and in-Vivo Animal Work
• Immunochemistry