1. Isaac Mall, M.B.A.
108 Hasgate Drive Delmar, New York, 12054, (518) 421-9495, mall.isaac04@gmail.com
Experience
February 2014 – Present Intracom LLC at RegeneronPharmaceuticals Glenmont, NY
QualityAssurance ValidationConsultant
 Prepare equipment for qualification studies and execute validation according to: Approved Protocols,
Standard Operating Procedures and Current Good Manufacturing Practices
 Authoring, Executing, and Reporting:
o Temperature Mapping Protocols
o Cleaning Validation Protocols
o Clean Hold Validation Protocols
 Reviews, edits and approves:
o Protocol deviation notifications / investigations
o Corrective actions and change controls
o Regeneron’s Standard Operating Procedures
o Piping and Instrumentation Diagrams
o Automation evaluation reports and documentation submitted to the validation department.
 Data analysis from pre-determined criteria against Cleaning and Clean Hold Validation results
Manufacturing Industry Skills
 Attended annual Good Manufacturing Procedures training
 Received training for “Train the Trainer - Adult Learning Theory”
 Served as a training lead for cleaning and clean hold validation protocol
 “Five S” of Lean Manufacturing
Experience with the following Equipment:
 Bioreactors  Purification Systems
 Centrifuge  Refrigerators / Freezers
 Chromatography Skids  Ultra Filtration Skids
 Clean in Place Skids  Validator 2000
 Process Tanks
Education
August 2012 – May 2015 The Sage Colleges– Sage Graduate School Albany, NY
Master of Business Administration
August 2007 – May 2012 NewYork State University at Buffalo Amherst, NY
Bachelor of Science in Biology
Computer and Language Skills
 Proficient in Microsoft Word, Excel, PowerPoint,Outlook, Adobe Acrobat X
 Knowledge in Urdu, Hindi, Spanish, and Latin