Michael O. Skidmore, MS Ology Bioservices, Inc
Michael O. Skidmore, MS Ology Bioservices, Inc
Mr. Michael Skidmore is VP QA/QC and Site Quality Lead at Ology Bioservices in North Florida. He is a former FDA microbiologist with over 25 years’ experience in biopharmaceuticals in environmental monitoring, technical transfer, validation, process engineering, process development, R&D, and QA.
While a consultant he assisted clients such as Inovio, Adaptimmune, and CSL Behring bring ATMP products into Phase 1 /2 manufacturing and he led the Tech Transfer of Sanofi’s Dengvaxia from France to the US. In previous roles, he was at Merck as Assoc Director of Bio/Sterile Validation responsible for validation of containers and single use systems for aseptic processing, intermediate, and finished goods and containers at the West Point site as well as leading a Center of Excellence to support the vaccine network with physical and microbiological testing of single use systems, filters, syringes and vials.
Michael has been an active member of the PDA for more than 15 years and is a current member of the PDA ATMP Advisory Board. He co-authored the PDA Technical Report No 60-2: Process Validation: A Lifecycle Approach - OSD/SSD Annex and is current chair of the working group PtC on Control Strategies for ATMP Vectors and Plasmids.
While a consultant he assisted clients such as Inovio, Adaptimmune, and CSL Behring bring ATMP products into Phase 1 /2 manufacturing and he led the Tech Transfer of Sanofi’s Dengvaxia from France to the US. In previous roles, he was at Merck as Assoc Director of Bio/Sterile Validation responsible for validation of containers and single use systems for aseptic processing, intermediate, and finished goods and containers at the West Point site as well as leading a Center of Excellence to support the vaccine network with physical and microbiological testing of single use systems, filters, syringes and vials.
Michael has been an active member of the PDA for more than 15 years and is a current member of the PDA ATMP Advisory Board. He co-authored the PDA Technical Report No 60-2: Process Validation: A Lifecycle Approach - OSD/SSD Annex and is current chair of the working group PtC on Control Strategies for ATMP Vectors and Plasmids.