Mark Dimartino

About Mark Dimartino

I am a data science professional with a diverse background in the biotechnology and medical device industries, having led and contributed to nearly all aspects of operations—including process development, quality, manufacturing, supply chain, and analytical method development. Over the course of my career, I’ve developed a deep passion for harnessing the power of data to drive better, faster decisions and more efficient, reliable operations.My core strength lies in integrating data science, statistical analysis, and domain expertise to transform complex datasets into actionable insights. I specialize in working cross-functionally to identify opportunities where data can unlock value across the product lifecycle, from early development through commercial operations.In my current role at Allogene, I’ve led key initiatives in the cell therapy space, including devising a successful comparability strategy across multiple technology transfers, establishing a comprehensive data strategy, and advancing product and process understanding for CAR-T therapies. These efforts have helped strengthen the foundation for scalable, high-quality manufacturing and regulatory readiness in a rapidly evolving therapeutic area. Prior to this I championed the formation of a data science team for a quality organization, pioneering the use of large language models to promote quality excellence.I’m energized by challenges that require both strategic thinking and technical depth, and I enjoy collaborating with mission-driven teams focused on innovation, quality, and continuous improvement.KEY SKILLSCross functional leadership and team building | Automated data analysis tool development | Large Language Models (LLMs), Machine Learning (ML)| Lean and Six Sigma | Process and Test Method Validation | Biologics and Cell Therapy | Public speaking and executive communication | Structured problem solving | Design of Experiments (DOE)| Process Capability Analysis | Continued Process Verification (CPV)

Experience

1. Senior Director Global Cmc Statistics

   Amgen

   Aug 2025 — Present · CO, US

   Provide strategic oversight and statistical leadership across Amgen’s pipeline and commercial products. Responsible for advancing excellence, automation and innovation in statistics support for control strategies, trending, process characterization and predictive modeling. In alignment with Amgen’s technology and workforce strategy, champion innovation in data science, automation, and predictive analytics to enhance decision-making and operational efficiency across the organization.

Education

• University of Illinois Urbana-Champaign

  Bachelor's degree, Cell/Cellular and Molecular Biology

• DePaul University

  Master of Science - MS, Applied Statistics

Skills

• Change Control
• Quality System
• V&V
• Cross-Functional Team Leadership
• Life Sciences
• Medical Devices
• Design Control
• Capa
• Biotechnology
• Quality Assurance
• 21 Cfr Part 11
• Technology Transfer
• Process Control
• Validation
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Sop
• Fda
• Quality Control
• Gmp
• Iso 13485
• Corrective and Preventive Action (Capa)
• Standard Operating Procedure (Sop)
• Biopharmaceuticals