1. Isaac Mall
33 Second Street Troy, New York 12180, (518) 421-9495, mall.isaac04@gmail.com
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SUMMARY:
Three years of experience in the bio-pharmaceutical industry. Responsible for the qualification of Cleaning Validation,
Clean In Place (CIP) and Clean Hold Validation studies on manufacturing equipment and Controlled Temperature Units
(CTUs); in addition to generation of summary reports and protocols for cleaning validation.
EDUCATION:
 Masters in Business Administration - The Sage Colleges - Sage Graduate School, Albany NY 2015
 B.S., Biology, New York State University at Buffalo, Amherst, NY 2012
PROFESSIONAL EXPERIENCE:
Regeneron Pharmaceuticals - Validation Consultant Feb 2014 – Present
Rensselaer,NY
 Prepare equipment for qualification studies and execute validation according to: Approved Protocols, Standard
Operating Procedures and current Good Manufacturing Practices (cGMP)
 Generation, Execution, and Summarization of :
- Temperature Mapping Protocols
- Cleaning Validation Protocols
- Clean Hold Validation Protocols
 Review and Revise the following documentation:
- Protocol deviation notifications / investigations
- Corrective actions and change controls
- Regeneron’s Standard Operating Procedures
- Piping and Instrumentation Diagrams
- Automation evaluation reports and documentation submitted to the validation department
 Data analysis from pre-determined criteria against Cleaning and Clean Hold Validation results
MANUFACTURING INDUSTRYSKILLS:
 Annual Good Manufacturing Practices training
 Train the Trainer - Adult Learning Theory
 Training lead for cleaning and clean hold validation protocol execution
 “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