Sharif Ahmed, PhD
Bayer
Associate Director - Process, Cleaning Validation and CPV
• Management, leadership and hands-on roles in Quality Systems, Validation, Product Development & Transfer, Start-up, Scale-up & Process Changes, Stability and Clinical Trials for biopharmaceuticals and medical devices.
• Successful commercialization of medical device/IVD products from their inception in R&D, development through Design Control and final FDA 510(k) Premarket Notification, Canadian Medical Devices Regulations (CMDR) and CE Marking for Class II Medical Devices.
• Providing Process validation support for IND (CMC) and NDA (CMC) filings for biologics.
• Managing, prioritizing, and leading long-range process, equipment, and technology development programs toward improving and optimizing manufacturing operations.
• Providing technical leadership through mastery of experimental design, complex troubleshooting, and advanced data analysis techniques; planning for campaigns and leading new product introductions; and recommendation and implementation of new technologies and operational strategies.
• Managing manufacturing, process development, process engineering, process validation in large and small-scale cell culture, large and small-scale microbial fermentation, large-scale protein purification, aseptic fill and finish.
• Certified in Lean Six Sigma Green Belt
• In-depth working knowledge of FDA, EMA, ICH, Health Canada, PDA and ISPE Guidelines on Process Validation Lifecycle.
• Sound knowledge of EU, US, Japan, and ICH cGMPs
Associate Director, Quality Unit-Process Validation
Bayer HealthCare
August 2014 – Present
Manager, QA Validation
BioMarin Pharmaceutical Inc.
May 2012 – August 2014
Division Production Manager, Manufacturing Operations Division, Life Science Group
Bio-Rad Laboratories, Inc.
March 2011 – April 2012
Manufacturing Engineer III, Quality Systems Division, Clinical Diagnostics Group
Bio-Rad Laboratories
July 2008 – February 2011
Scientist, Research and Development, Quality Systems Division, Clinical Diagnostics Group
Bio-Rad Laboratories
February 2006 – June 2008
Scientist, Research and Development
Prozyme, Inc.
December 2003 – January 2006
Post-docotoral Fellow, Molecular & Cell Biology
University of California, Berkeley
February 2000 – December 2003
• Successful commercialization of medical device/IVD products from their inception in R&D, development through Design Control and final FDA 510(k) Premarket Notification, Canadian Medical Devices Regulations (CMDR) and CE Marking for Class II Medical Devices.
• Providing Process validation support for IND (CMC) and NDA (CMC) filings for biologics.
• Managing, prioritizing, and leading long-range process, equipment, and technology development programs toward improving and optimizing manufacturing operations.
• Providing technical leadership through mastery of experimental design, complex troubleshooting, and advanced data analysis techniques; planning for campaigns and leading new product introductions; and recommendation and implementation of new technologies and operational strategies.
• Managing manufacturing, process development, process engineering, process validation in large and small-scale cell culture, large and small-scale microbial fermentation, large-scale protein purification, aseptic fill and finish.
• Certified in Lean Six Sigma Green Belt
• In-depth working knowledge of FDA, EMA, ICH, Health Canada, PDA and ISPE Guidelines on Process Validation Lifecycle.
• Sound knowledge of EU, US, Japan, and ICH cGMPs
Associate Director, Quality Unit-Process Validation
Bayer HealthCare
August 2014 – Present
Manager, QA Validation
BioMarin Pharmaceutical Inc.
May 2012 – August 2014
Division Production Manager, Manufacturing Operations Division, Life Science Group
Bio-Rad Laboratories, Inc.
March 2011 – April 2012
Manufacturing Engineer III, Quality Systems Division, Clinical Diagnostics Group
Bio-Rad Laboratories
July 2008 – February 2011
Scientist, Research and Development, Quality Systems Division, Clinical Diagnostics Group
Bio-Rad Laboratories
February 2006 – June 2008
Scientist, Research and Development
Prozyme, Inc.
December 2003 – January 2006
Post-docotoral Fellow, Molecular & Cell Biology
University of California, Berkeley
February 2000 – December 2003