Tom Smith

About Tom Smith

Biologics professional with ~15 years of industry experience - 9 years managerial - overseeing the successful launch of GxP teams (pre-clinical through commercial) as large as ~40 personnel.Managerial experience has included oversight of: QC Analytical, Microbiology, Raw Materials, Stability, Technical Services, External CTL and CDMO Management, Client Program Management, Viral Clearance, and interim oversight of Analytical Development. These roles span viral vector based gene therapies (AAV, retroviral, oncolytic adenoviral), cell therapy, monoclonal antibodies, ADCs, AOCs, other recombinant proteins, therapeutic plasmid, RNAi, viral vaccine, toxoid vaccine, and cell banking modalities. Extensive experience representing noted functions for pre-approval inspection (internal and external/regulatory).

Experience

1. Director, Quality Control

   KBI Biopharma

   Jan 2024 — Present

   Responsible for the launch and operations of KBI’s Hamlin site QC department.

Education

• The Johns Hopkins University

  Master’s Degree, Biotechnology

  2012 — 2015

• Penn State University

  Graduate Certificate, Applied Statistics

  2015

• James Madison University

  Bachelor of Science, Biology Major; Chemistry Minor; Pre-Medical Concentration

  2006 — 2010

Skills

• Sop Development
• Conductivity
• Lims
• Bioburden
• Aseptic Technique
• Kaizen
• Endotoxin
• Statistical Data Analysis
• Pcr
• Molecular & Cellular Biology
• Six Sigma
• Capa
• Qualified Trainer (on Lab Procedure)
• Biotechnology
• Microsoft Office
• Sql
• 5s
• Microbiology
• Protein Chemistry
• Gmp
• Change Control
• Immunology
• Toc
• Deviation Management
• Dna
• Oos
• Western Blotting
• Biochemistry
• Glp
• Yellow Belt (Six Sigma)
• Technical Documentation
• Technical Writing
• Elisa