1995 -
1997 Various @ Temporary Validation Positions
Jim Leeper Education
Kutztown University
Master Of Education (Biology, Education)
1993
-
1999
Jim Leeper Skills
Sterilization
APS
Validation Master Plans
CIP
Equipment Qualification
Computer System Validation
cGMP manufacturing
Qualification
GMP
21 CFR Part 11
Process Validation
GxP
Commissioning
Biotechnology
Change Control
Regulatory Affairs
Validation
Trackwise
Cleaning Validation
Sop
Purification
Quality System
Risk Assessment
V&V
Pharmaceutics
Deviations
FDA GMP
Risk Assessments
Biologics
Deviation Management
Vaccines
Regulatory Submissions
Formulation
Project Management
Pharmaceutical Industry
Technology Transfer
Aseptic Processing
GLP
LIMS
CAPA
Computer System
FDA
Environmental Monitoring
Lyophilization
Process Simulation
Biopharmaceuticals
Jim Leeper Summary
Jim Leeper, based in Boston, MA, US, is currently a Director, Validation at Celldex Therapeutics. Jim Leeper brings experience from previous roles at Nitto Denko Avecia Inc., Sanofi Pasteur, In Vitro Technologies and Human Genome Sciences. Jim Leeper holds a 1993 - 1999 Master Of Education in Biology, Education @ Kutztown University. With a robust skill set that includes Sterilization, APS, Validation Master Plans, CIP, Equipment Qualification and more. Jim Leeper has 1 emails and 2 mobile phone numbers on RocketReach.
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