John Tomtishen

Experience

1. Vice President of Operations (Head of Idmo Business)

   Cellares

   Oct 2021 — Present

   As part of the Executive Leadership Team, developed and successfully executed against a comprehensive business strategy to establish a Best-in-Class, Customer Centric Global Cell Therapy Integrated Development and Manufacturing Organization (IDMO) through a vertically integrated business model with our Life-Science Technology Business Unit. Direct oversight and accountability over Cellares’ IDMO with operations in South San Francisco, CA and Bridgewater, NJ. Worked closely with the Executive Leadership Team to develop a robust Go-to-Market strategy and facilitate market adoption of the Cell Shuttle to transform the cell therapy manufacturing paradigm. Developed a Global IDMO roadmap and framework to drive strategic growth investments and market penetrance of Cellares’ IDMO. Oversaw the buildout of Cellares\' Technical Operations and Process Sciences team that worked closely with our Research and Engineering teams to support the development and launch of the Cell Shuttle, while driving partnership activities to adopt and integrate the Cell Shuttle into manufacturing workflows across a variety of cell therapeutic modalities. Played an integral role in establishing relationships with cell and gene therapy developers and building out our business model and capabilities for our Early Access Partnership and Technology Adoption Programs. Worked closely with our Quality and Regulatory teams to develop our Global Regulatory Strategy for the commercial launch of the Cell Shuttle. Played an integral role in all interactions with global health authorities, including filings, meetings, and general correspondence. Served as a core member of the New Product Introduction process to evaluate new products and technologies in support of our global business model.

Education

• Bucknell University

  Bachelor of Science with Honors, Cell Biology/Biochemistry

  2007 — 2011

• Mount Carmel Area

  High School Diploma

  2003 — 2007

Skills

• Hplc
• Cgmp Practices
• Process Development
• Minitab
• Scale-Up
• Molecular & Cellular Biology
• Cancer Research
• Jmp
• Simca
• Leadership
• Lean Manufacturing
• Continuous Improvement
• Process Optimization
• Molecular Virology
• Process Characterization
• Kaizen
• Protein Purification
• Six Sigma
• Confocal Microscopy
• Protein Expression
• Process Transfer
• Green Belt
• Project Management
• Yellow Belt
• Electronic Lab Notebooks
• Operational Excellence
• Multivariate Statistics
• Root Cause Investigation