Nick Kaiser

Leading data science initiatives for cell therapy manufacturing processes

• • Built and deployed PostgreSQL database for process development data on Kubernetes
• • Developed internal R package (harpde) for manufacturing dataset analysis
• • Implemented automated services for clinical manufacturing data pipelines
• • Provided statistical leadership on process characterization and SPC

Led process development for commercial hematopoietic stem cell therapies

• • Directly supported BLA and MAA submission and approval for Skysona and Zynteglo
• • Designed late-stage process characterization studies using DOE methodologies
• • Managed team of five process scientists in filing section authorship
• • Led comparability analysis across manufacturing process development history

Cardiac tissue engineering research with novel biomaterial platforms

• • Designed tunable collagen fiber scaffolds for cardiac applications
• • Developed engineered cardiac tissues using stem cell-derived cardiomyocytes
• • Applied DOE approaches with chemical, histological, and mechanical assays
• • Published 4 peer-reviewed papers in tissue engineering journals

Led lyophilization process development for autologous cellular cartilage products

• • Developed and optimized lyophilization process for tunable collagen tissue scaffolds
• • Designed and executed DOE studies to identify critical process parameters
• • Created bench top assays for scaffold density, thickness, and pore characterization

Developed dermis tissue products using collagen hydrogel platforms

• • Developed dermis products with collagen hydrogels seeded with fibroblasts and keratinocytes
• • Applied DOE and Quality by Design principles for analytics optimization
• • Ensured compatibility with commercial manufacturing processes

Supported R&D and marketing with implantable medical device testing

• • Conducted testing of implantable medical devices in vitro and preclinical models
• • Performed advanced image and mechanical analyses of tissues and devices
• • Studied in vivo resorption characteristics of silk scaffold materials

Designed experimental procedures for tissue scaffold characterization

• • Designed novel experimental procedures for in vitro and in situ tissue scaffold testing
• • Authored technical reports and presentations for R&D, marketing, and executive teams
• • Gained experience in medical device development and regulatory processes