Timothy Lutz

About Timothy Lutz

I have over ten years of experience in leading the site operations, team building, CDMO relations, facility expansion, and validation for fast-growing biotech company\'s. I have experience acquiring sites for future manufacturing, and negotiating over $36M in incentives, and building a production team to support Phase clinical and c9mmercial operations. I have been responsible for establishing a global multi-facility network for the production of cell- and virus-derived therapies and vaccines. I also led operational completion and regulatory readiness of the world\'s largest cell and viral therapy facility. I have a strong background in aseptic manufacturing (34 years), technology transfer, BLA authoring, facility build-out and start-up, process scale-up, and audits. I hold a BS in Business Management. I am passionate about advancing the field of cell and gene therapy and delivering life-changing treatments to patients.

Experience

1. VP Manufacturing and Operations

   Transpire Bio

   Jul 2024 — Present · Weston, FL, US

   Lead all Supply Chain, Manufacturing, Validation, IT, EHS, Facilities and Engineering from R&D into Clinical/Commercial Operations. Tasked with identifying, acquiring, designing, and building new R&D/clinical/commercial manufacturing to support the inhalation business, including Dry Powder Inhalers (DPI) and Soft Mist Inhalers (SMI). Modify existing facilities to support on-going cGMP operations and future R&D operations- Led hiring of new staff during accelerated growth of company- Led team during the design and build of new manufacturing facility- Identification / implementation team for ERP- Secured additional office space and R&D/clinical manufacturing space- Developed timelines for construction and transition- Interfaced with clients and local authorities- Led acquisition /qualification of isolated filling machine and support equipment

Education

• York College of Pennsylvania

  BS

• University of Phoenix

  MBA

• Harvard University

  Certificate Program

  2019

• Kent State University

  BS