Jim Leeper Email & Phone Number
Director, Validation @ Celldex Therapeutics
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Jim Leeper Location
- Boston, MA, US
Jim Leeper Work
- 2016 -now Director, Validation @
- 2014 -2016 QA Validation Manager @
- 2005 -2014 Deputy Director Validation @
- 2003 -2005 Senior Validation Engineer @
- 2001 -2003 Validation Engineer Iii @
- 1997 -2001 Senior Engineer @
- 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 2 emails and 2 mobile phone numbers on RocketReach.
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