Associate Director, Quality Operations @ Managing the Quality Operations group including Lot Release, MQA, and Supplier Quality as well as oversight of the Validation/Qualification program and the Change Control and Quality Risk Management systems at Roche Carolina. From September 2014 to Present (1 year 4 months) Head of Quality Engineering and Validation @ Managing the Quality oversight of the Validation/Qualification program and the Change Control Process and Quality Risk Management systems at Roche Carolina. From June 2013 to August 2014 (1 year 3 months) Principal Technical Manager, External QA (Contract Manufacturing) @ Quality oversight of Genentech's contract manufacturing organizations specializing in aseptic filling/lyophilization, medical devices, and final packaging. Significant experience in technical transfers, quality agreement negotiation, validation/qualification review, leading quality investigations, change control, lot release, and health authority submissions/audits. Experience included both remote sites in the US and Europe and person-in-plant roles. From July 2003 to June 2013 (10 years) Senior Supervisor - Filling/FD @ - Bayer Corporation Presidential Achievement Award in 1998 for design, validation, and implementation of a purification process improvement to increase product recovery. - Awarded Bayer Premier Circle Award in 1999, 2000, and 2002. - Recipient of Bayer Quality Excellence Award in 2001 for process improvement that led to improved product purity and recovery From 1994 to 2003 (9 years)

Villanova University Lean Six Sigma Black Belt Certification Program @ Villanova University From 2013 to 2013 Genentech Quality Certification Program From 2011 to 2011 Association for the Advancement of Medical Instrumentation (AAMI) From 2007 to 2007 University of California Berkeley Extension From 1995 to 1995 Bachelor’s Degree @ University of California, Berkeley From 1990 to 1994 Adam Pinkert is skilled in: Aseptic Processing, Technology Transfer, Biotechnology, CAPA, GMP, Validation, FDA, Pharmaceutical Industry, Regulatory Affairs, Lyophilization, Biopharmaceuticals, Quality System, Lifesciences, Medical Devices, Process Simulation