Michael Skidmore Email & Phone Number
PDA Regulatory Authority Engagement Liaison for the EMA Biologics Working Party @ PDA - Parenteral Drug Association
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Michael Skidmore Location
- Philadelphia, PA, US
Michael Skidmore Work
- PDA Regulatory Authority Engagement Liaison for the EMA Biologics Working Party @ (July 2024 - Present)
- Principal Managing Partner @ Pharmaceutical Quality Consulting, Inc. (October 2011 - Present)
- Head of Quality and Regulatory @ (July 2022 - September 2023)
- Head Of Quality @ (November 2021 - December 2022)
- CMC Program Manager, EZ-PLAS @ (November 2021 - March 2022)
- Head of Quality @ (November 2021 - Present)
- CMC Program Manager, Ez-Plas @ (November 2021 - Present)
- Head of Quality, Florida Site @ Resilience (April 2021 - October 2021)
- Vice President QA and Qc Quality Site Lead @ (October 2020 - October 2021)
- Principal @ Pharmaceutical Quality Consulting, Inc. (October 2011 - April 2021)
- Contracted Supplier Auditor @ (June 2019 - October 2020)
- Senior Auditor, Independent Consultant @ (February 2016 - March 2019)
- Overall Technology Transfer Lead and Facility Startup Pmo @ (June 2017 - January 2018)
- Independent Consultant @ (July 2016 - January 2017)
- North America Tech Transfer Lead and Lead Process Designer, Dengvaxia and Yf-Vax @ (March 2013 - March 2015)
- Senior Consultant @ Eli Lilly and Company (July 2013 - December 2013)
- Consultant Project Engineer, Vaccines Technology and Engineering @ (June 2013 - August 2013)
- Senior Auditor, Independent Contractor @ (December 2012 - April 2013)
- Senior Consultant in Oral Liquids Dosage Facility @ (March 2012 - September 2012)
- Associate Director, Bio and Sterile Validation @ (June 2009 - April 2012)
- Interim QA Manager in Aseptic Liquids Filling, Confidential Parenteral MFG Client @ (October 2011 - February 2012)
- Consultant in Bio and Sterile Validation Department @ (October 2008 - December 2008)
- Principal Validation Engineer and Project Manager @ (January 2006 - January 2008)
- Consultant @ (March 2006 - September 2006)
- Senior Pharmaceutical Consultant @ (December 2004 - March 2006)
- Consultant and Project Manager @ (February 2005 - February 2006)
- Microbiology Analyst and Investigator @ (January 2003 - January 2004)
- Consultant @ (January 2003 - January 2004)
- Consultant, Validation @ (January 2002 - January 2003)
- Military Policeman, Unit Adminstrator @ (January 1984 - January 2000)
Michael Skidmore Education
- UC San Diego School of Medicine
MS (Molecular Pathology)
1995-2000 - University of Salamanca (Universidad de Salamanca)
Minor Concentration (Spanish Language and Culture)
1998-1998 - UC San Diego
BA (Biochemistry and Cell Biology)
1985-1990
Michael Skidmore Skills
- Aseptic Processing
- filter validation
- Container closure integrity
- GMP
- Cleaning Validation
- Project Management
- FDA
- Equipment Qualification
- Change Control
- Pharmaceutical Industry
- CAPA
- 21 CFR Part 11
- Sop
- Technology Transfer
- Biotechnology
- Quality System
- Medical Devices
- Regulatory Affairs
- Biopharmaceuticals
- Validation
- Consent Decree Remediation management
- Process Validation
- Antibody manufacturing
- Vaccine manufacturing
- Single Use Systems Testing
- OSD
- Oral Liquids Dosage
- Terminal Sterization
- MS Project Server
- Minitab
- Lean Six Sigma
- Statistics
- Quality Assurance
- Quality Engineering
- recombinant DNA technology
- Cell Culture
- Protein Purification
- Microbiology
- Pharmaceutics
- Six Sigma
- Drug Development
- Design Control
- Chromatography
- Clinical Trials
- Project Server
- Regulatory Submissions
- LIMS
- Sterilization
- Consent Decree
- GLP
Michael Skidmore Summary
- Michael Skidmore, based in Philadelphia, PA, US, is currently a PDA Regulatory Authority Engagement Liaison for the EMA Biologics Working Party at PDA - Parenteral Drug Association. Michael Skidmore brings experience from previous roles at Pharmaceutical Quality Consulting, Inc., Blue Water Biotech Inc., SOTIO Biotech Inc. and Teleflex. Michael Skidmore holds a 1995 - 2000 MS in Molecular Pathology @ UC San Diego School of Medicine. With a robust skill set that includes Aseptic Processing, filter validation, Container closure integrity, GMP, Cleaning Validation and more. Michael Skidmore has 4 emails and 2 mobile phone numbers on RocketReach.
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