Nicholas Deprimo

About Nicholas Deprimo

Experienced Process Development People Leader and Scientist focusing on rAAV gene therapies with extensive history of monoclonal and bi-specific antibody development through process validation and commercialization. Leading the Drug Substance Team for Spark Therapeutic\'s late phase asset through process development, characterization, Process Performance Qualification (PPQ). Managing scientists ranging from contractors through Associate Director roles to develop their technical and professional skill sets to set Spark up for continued success. Strong pharmaceutical process development skills in Quality by Design (QbD), Design of Experiment (DOE), CMCs, Technical Writing, upstream and downstream process scale-up/scale-down, technology transfer, and regulatory documentation (multiple BLAs, INDs, and Briefing Book packages) as well as post-approval submissions. Master of Science with 15 years of industry experience.

Experience

1. Director - Cell Culture Process Development

   Genentech

   Jul 2025 — Present · Philadelphia, PA, US

   Leading cell culture and bioreactor process development team of 10+ scientists in support of process optimization, process characterization, and process performance qualification (PPQ) across early and late-phase products within the Roche Innovation Center - Philadelphia (RICP) portfolio- Managing 10+ direct reports ranging from Research Associates through Principal Scientists, as well as external contractors- Leading Drug Substance Working Group (DSWG) team within late-phase asset CMC Team to progress asset into PPQ readiness including regulatory filing and briefing book authorship- Coordinating technology development activities related to upstream process stages to improve cell health, productivity, and product quality of material entering downstream purification process via use of new equipment, scale-up/scale-down optimization, evaluation of alternative raw materials and operational workflows- Collaborating with Roche and Genentech colleagues within global Cell Culture Team to drive gene therapy innovation and pipeline progress, including due diligence and business strategy alignment

Education

• Drexel University

  M.S., Biomedical Science

  2007 — 2009

• Penn State University

  B.S., B.S., Biochemistry and Molecular Biology, Psychology with Neuroscience concentration

  2002 — 2006

Skills

• Cell Culture
• Chromatography
• Gmp
• Aseptic Technique
• Laboratory
• Data Analysis
• Glp
• Assay Development
• Mammalian Cell Culture
• Filtration
• Validation
• Biotechnology
• Customer Service
• Technical Writing
• Viruses
• Ion Exchange
• Scientific Writing
• Viral Clearance
• Viral Filtration
• Virus Inactivation
• Tech Transfer
• Early Phase Development
• Late Phase Development
• Akta Chromatography
• Ambr15
• Ambr250
• Vicell
• Cedex
• Laboratory Skills
• Life Sciences