Adjunct Professor

• Aug 2022 - Present

Professor for BUS001, a course for prospective Business Undergraduates to provide a practical and interactive overview of the major functions of business taught by current and recently retired executives. Professor for BUS001, a course for prospective Business Undergraduates to provide a practical and interactive overview of the major functions of business taught by current and recently retired executives.

Vice President Business Consulting

• May 2022 - Present

Mike Shafer is a Vice President of Business Consulting leading the Life Sciences Industry Practice at CGI. He is dedicated to helping clients in the Health and Life Sciences sectors improve their methods and better leverage human capital to produce the highest quality, most innovative products for public health at the lowest possible cost.

Director of Consulting Delivery

• Dec 2017 - May 2022

Mike leads a team of experienced Subject Matter Experts supporting Clinical, Regulatory, GxP Quality, Laboratory, Manufacturing, and Commercial Operations for CGI's Life Sciences clients. He and his team collaborate across accounts and geographies to deliver thought leadership, best practice guidance, business process / gap analysis, and solution implementation partnership at each stage of the product life-cycle.Mike's team has engaged with a full spectrum of clients from biotech start-ups to the largest global pharmaceutical firms and has assisted clients across therapy areas from generics, through combination products / devices, to cell and gene therapies. Show less

Associate Director, Quality & Manufacturing

• Oct 2017 - Dec 2017

Mike is the Quality Management Systems Offering Lead for Paragon’s Quality and Manufacturing domain. In this role, he assists Quality and Operations teams in defining strategy, process design, and quality transformation. He is a former Naval Officer and Management Consultant with over 10 years of experience in the pharmaceutical industry. Mike joined Paragon from a global professional services firm, where he focused on 21 CFR Quality/Compliance and its impact on the supply chain. Prior to consulting he worked in industry, focusing on commercial scale-up, facility start-up, regulatory compliance, validation, cGxP Operations, Quality Management, and agile/lean production. He has an MBA from Lehigh University and a B.A. in Chemistry and Chemical Biology from Cornell University. Show less

Manager, Life Sciences Advisory

• Oct 2016 - Oct 2017

Leading transformational engagements in Quality Assurance, Validation, Quality Control, Regulatory Compliance, cGMP Manufacturing, and SC&O in the Life Sciences industry.

Senior, Life Sciences Advisory

• Mar 2015 - Oct 2016

Assisting Life Sciences clients with business transformations, projects, and opportunities with a focus on Supply Chain and Operations, Manufacturing, and FDA Compliance.

Senior Manager, Aseptic Filling

• Oct 2013 - Mar 2015

Managing, scheduling, and staffing 5 Aseptic filling lines producing both live and inactivated vaccines. Deviation, Change Control, and CAPA management. Driving a Single Minute Exchange of Dye (SMED) to improve manufacturing efficiency and reduce operator errors. Ensuring the use and accuracy of Overall Equipment Effectiveness (OEE) monitoring. Personnel mentoring and development.

Senior Manager, Antigen Manufacturing

• Sep 2012 - Oct 2013

Manager, Quality Assurance

• Sep 2010 - Sep 2012

Senior Manufacturing Specialist, Influenza Manufacturing

• Feb 2009 - Sep 2010

Public Affairs Officer

• 2008 - 2009

Strike Warfare Officer & Legal Officer

• 2007 - 2008